UNIVERSITÀ DEGLI STUDI DI TORINO · 2015-10-06 · UNIVERSITÀ DEGLI STUDI DI TORINO ESAME DI...

UNIVERSITAgrave DEGLI STUDI DI TORINO

ESAME DI STATO PER LrsquoABILITAZIONE ALLrsquoESERCIZIO DELLA PROFESSIONE DI FARMACISTA

PRIMA SESSIONE 2015

PROVA SCRITTA

Tema n 1 Distribuzione in nome e per conto (DPC) finalitagrave e modalitagrave operative Tema n 2 La contraccezione ormonale in farmacia principi farmacologici indicazioni drsquouso e rischi di interazioni Tema n 3 Le preparazioni oftalmiche definizione tipologie e requisiti

PROVA PRATICA Prova n1 Dosamento del farmaco Vedi allegato di seguito Prova n2 Riconoscimento del farmaco Vedi allegato di seguito Prova n3 Spedizione della ricetta Vedi allegato di seguito

UNJ)E8ilIAogQJSfJjBilJplIORINO

1~rSfJITOPffL~TADmI AtegraveN~LIlA~~SlONE DI FARMACISTA

PAtMASESsIONEOU

PWDVA tAfrtk PIViagrave tifi tittmOStirtriltltb del farmaco

cogravegtrOrt1e e hGme bull- - bullbullbullbullbullbullbullbullbullbullbullbullbullbullbull - bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

1l(J~ttQto(QtrSigravegteamp~~~ittietttQmiddotdldtJfffam

Per ogni farmocO vIene fornilo il profilO sperimenfale (sequenza delle analisi effettuate] ed UtrCl irigraveoieCIZione di pdssibHi for1YlOci candidati corredati dalle rispettive monografie provenienti dolio Farmacopea Europea (Ph Eur 8)

AI candidato viene riChiesto di

bull individuerei fortntJegraveO che megfio cOOi~pondeal profilo fornito mOtivare lJre~emeacutenteacute lO propria scelto proporregrave unulteriore provo sperimentale CI Conferma della scelta effettuata

~1N~ntba~I~Pfi1fO(~

ntarl11Qco In esome si presenta come unO pegravelvere Cristallina bianca o quasi bldhca ed ha una solutlmtagrave in ogravecqua pari a 1 gml Quot1dO la soluziorre acquoso del farmocograve ccrdigraveficota con HN03 diluito viene trattata con AgNOssi origina un precipitato bionco caseoso

In oose a qlJeste caratteristiche ed CI tOle comportamento sono stati individuati tra igrave formcci a disposizione 3 possibili candidati ~rina cloridrato procaina Clotrtlmto difeacuter1idrQmirra clOrtdrato

o (agrave1 011 ~ I ~ 1411 I~O~N~CH3 O~NCH3

~ CH3 Ha HCIcn CH3

H2N~ tfCI

efedrina cloridrato prbcaina Clotidnlto difenidramina cloridrato

Tenendo presente che

bull trattando lo sollJzione del forthoco rn questione in HCI diluito con NaN02 e 5uccegravessivcrmenteacute con unugrave soluZione di ~ntlftolo non si osserva alcun cQmbiamenfo di colorazione

bull Id soluzione acqwosa del farmaco in ClUestione non mostra reattivitagrave in presenza di CUS04 in ambiente bcasico

indigravecore quale farmaco corrisponde al profilO sperimentale fornito motivando brevemente tale scelta e proporre almeno unulteriore prova sperimentale per validare lo scelta effettuato

RlrotrOegraveimeacutettto ciel fatrnCco secontfo tfctJftOlaquo11mmto

Il fdrmaco in esame si presenta Comeacute polvere cristallina bianca o quasi bianca Con una solubiUtagrave in acqua pH dIpendenteacute (diminuisce a pH acido)

Quando la soluzione del farmaco in NoOH diluito viene trattata con FeCb si sviluppa una colorazione violetta che persiste ClllChe dopo aggiunta di CH3COOH

h oose Cl queste cOrcltterrsticne ed a tale eacuteogravempoftdftiento sono stati individuati tra ifol111oci a dispOsitione 2 possibili candldatigrave tteRf6 saJictrrco e sallcilato sodico

~~ 2 0O OH - Na

~OH ~OH acido salicilico sodrO salieilato


il faJmerco in questione ha uno solwbllitagravepdrl a circa 1 gI in acqua e che egrave1uegraveSto risulta decisamente piugrave elevato circo 1 Qmi in EtOH

indteacuteare a quale dei due farmaci corrisponde il profilo sperimentale fornito motivando tale scelta e prOpofre almemo unulieriOre prova sperimentale per vdndore lo scelta effettuata

EUROPEAN PHARMACbPOgraveEIA 80

~ t

23 rDENTlFrCATION

011200amp20301

231 mENTIFICATION REACTIONS OF IONS AND FtJNCTIONAL GROUPS ACETATES

a) Heat the substanCe fu be eialllined wigravetb ltIn equal qumUty ogravef oxalil lcid R Add vltpours wigravetb the characterisliC ad61l1 ai afiefic acid aie libented shoWing ltIn acid reaegravetion (224)

b) DissOlve abolIt 30 mg of the substance to be egravewiiled ln 2gt tnL or Wltegrave R dI use 3 tnL et tbe presctibed solution Add SlKcessigravevegravely 025 mL etUtnthanum nittate solutiitn R 01 mI df 005 M iodigrave1le and 005 mL of diIlJte ammlJttia R2 Heat ~milly tu boiling Within a few ininutes a blue predpitate iS fotmed or a diltk blue colour dlVelops

ACETYL

In a testmiddottube about 180 Dm long and 18 = in extemal diameter plaegravee about 15 mg of the substance to be examined or tbe prescribed quantity and 015 mL ofphosphoric acid R Close the tube with a stopper through whidl passes a small test-tube about 100 nun long and 10 mm in external digraveametet contagraveining water R to ad as a condenser On the outside tJf tne smal1er tube hang a drop of lanthanum nirrate soutigraveon R EXigraveept for substances hydrolysable onIy with difficuhy piace the apparatus in a water-bath for 5 min then tagraveke out tbe smagraveller tube Remove tbe drop and tnix it with 005 mL of 001 M iadine on a tile Add at the edge 005 mL of dilute ammDnia R2 Mer l min to 2 inin a blue colour devclaps at the junaion of thc two rlmps tbe coloU intensifies and persists for a mort time

For substances hydrolysable only with difficulty heat thc tnixture slowly to boiling over an open flame md then proceed as prescribed above

ALKALOIDS

Dissolve a few milligrams of the substance to be examined or the prescribed quantlty in 5 mL of water R add dilute hyigravelrochloric lcid R until an acid reaction occurs (224) then 1 mL ofpolilS$ium iodobismuthate solution R An orange or Olange-red precipitate i5 formed immediately

ALuMINlUM

DissOlve about 15 mg of the substance to be exatnined in 2 mL of water R or use 2 mL of the prescribed solution Add about 05 mL of dilute hydrochloric acigraved R and about 05 mL oE thioacetamide reagent R No precipitate is forrned Add dropwigravese dilute sodium hydroxide solution R A gelatinous white precipitate is formed which dissolves on further addition of dilute sodium hydroxide solution R Gradually add ammonium ehoride solution R The gelatinous white precipitate is re-formed

AMINES PRlMARY AROMATIC Acidify the prescribed solution wigraveth diute hydrochIorie acid R and add 02 mL of sodium nitrite solution R Alter 1 inin tO 2 inin add l mL of ~-naphthol solution R An intense orartge or red colour and usually a precipitate of the same colour are produced

AMMONIUM SALTS

To the prescribed 50lut10n add 02 g of mlgnesium oxide R Pass a current of air through the tnIgravellture and direct the gas that escapes just beneath the surface of a mixture of l mL of 01 M hydrochloric acid and 005 mL of methyl red solution R The colour of the indigravecator changes to yellow On addition of l mL of a freshly prepared 100 gL solution of 50dium cobaltigravenitrite R a yellow precipitate is formed

GeneraI Notice5 (l) appy to ali monographs and other texts

2UMlltiftrirlbnnlirctions of ions and functional groups LAoIIIgraveo~

AMMomt1Nigrave SALTS AND SALTS OF VOLATILE BASES DiSlrolYeigravetbatit 20 mg of the substance fu be examined in 2 mL ofwdtegravet Rdr mi 2 mL of tbe prescribed solution Add 2 mL of drlIgravetlte S1ilfillffllfyatoxide solution R On heating the solution gives off Vagravepuur tnat can be identmed by its odour and by its allWilie reagravection (224)

ANTlMONY Disliolve with gegravefttle heating about lO mg of the substance to be exiigravelIitterd in a solution of 05 g of sodium potassium fltffrdte k in 10 mL of water R and allow to cool to 2 mL of this solirtkm or to 2 mL of the prescribed solution add SlJdiifm rtifiile SIigraverttion R dropwigravese m orange-red precipitate is fuftlled whicli di-soolveacuteS on addition of dilute sodium hydroxrdl1 soluIgraveiotl R

ARSEgraveNIC Heat 5 mL of tbe prescribed solution on a water-batb wigravetb an eqigraveW volume of hypophosphorous reagent R A brown precipitate is forllled

BARBITURATES NON-NITROGEN SUBSTITUTED DissOlve about 5 mg of the substance to be exatnined in 3 mL of methohol R add 01 mL of a solution containing 100 glI of eobalt nitrate R and 100 gL of calcium ehoride R Mix and agravedd With shaking 01 mI ofdIute sodium hydroxide solution R A iogravelegravet-blue colour and precipitate are formed

BBNZOATBS

a) To 1 mL ogravef theacute preseacuteribed solution add 05 mL offorric chIofide sdlrtffun R1 A dull-yellow precipitate soluble in ethegraver R rs fdtmeacuted b) Place 02 g of tbe substance to be examined treated ii neccssary as prtscr1bed in a test-tube Moisten wigraveth 02 mL to 03 mL ofsulfurit acid R Gently warm tbe bottom of the tube A white subIirnate igraves deposited on the inner wall of the tube

c) Dissolve 05 g of tbe substance to be examined in lO mL of water R or UIie 10 mL of the prescribed solution Add 05 mL of hydrochlorie acid R Tbe precipitate obtained after crystallisatiOIl from warm water R md drying in vacuo has a melting point (2214) of 120 middotC to 124 middotC

BISMUTH

a) To 05 g df the 5ubstance to be examined add lO mL ofdilute hyd1Oihliftigravec Ittid R or use lO mL of the presaibcd solution Hatt to boiling fuI 1mio eool and filter if necessary To l mL of the solutioIgravel obtained add 20 mL of water R A white ai slightly yellow precipitate is formed which OD addition of 005 mL to 01 mL of sodium 5ulfide soution R turns brolIl

b) To about 45 mg of the substance to be examined add lO mL of dilute nitrigravec add R or use IO mL of the prescribed solution Bail for l min Allow to cool and filter if necessary To 5 mL of the solution obtained add 2 mL of a 100 gL solution of thiourea R A yellowigravesh-orange colour or an orange precipitate is fcrrmed Add 4 mL of a 25 gL solution of sodium fluoride R The solution rs not decolorised within 30 inin

BROMIDES a) Dissolve in 2 mL of water R a quantity of the substance to be exarnined eqUivalint to about 3 mg ofbrornide (Br-) or use 2 mL of tbe prescribed solution Acidify with dilute nitric acid R and add 04 mL oE siIver nitrate soution Rl Shake and allow to stand A curdled pale yellow precipitate i5 formed Centrifuge and wash the precipitate with three quantities each of l mL of water R Carry out this operation rapidly in subdued light disregarding tbe fact that tbe supernatant solution may not become perfecdy dear Suspend the precipitate obtained in 2 mL of water R and add 15 mL of ammonia R The precipitate dissolves with difficulty b) Introduce into a small test-tube a quantity ofthe substance to be examined equivalent to about 5 mg ofbromide (Br-) or the prescribed quantity Add 025 mL of water R about 75 mg

119

231 IUgraveelItiIigraveclltion reattitll2S of ions md fograveuctiogravenal groups EUROPEAN PHARMACOPOEIA 80

ogravef liad diqmIe R 025 mI of acetic adii R and shake geiltly Dry We inSideacute of fuI uppel part of the test-tube wigraveW a pieccedile af filter paper arigraved aIlow to sand for 5 mm Prepare a sttigravep ofsUitable filter paper of appropriate SLze Itnpregnate it b] ClIpillatity by dipping We tip in a drop of decolorised fttcltsin solutitm R attd introduee the impregnateci part iIlllIgravelediarely itittl the tube Starting ampom the tip a violet colaur apPllllrs Wllliigraveil lO s Ihat is clearIy diStinguishligraveble fiIIl11 me led colout ogravef fuchsln whilth ma) be Vigtiblegrave Il a small area at me (ltYp C1f tlte impt1igravegtlagraveted Itart of tbe paper strip

cALtrJM a) To 02 igravetlL 6f a neutral solution contaibing a qtigravealltigravety m tbe suligravestabee lo be eilU1tined eqUivaleJit to almut 02 mg (J caldum (Caz+) per millilitre or to 02 mL ai the prescribed solUfion add 05 mL of a 2 gfL solution ofglyuxalhydrotyanil R in ethanol (96 per certt) R 02 mL of dilute sodium hydteuro1Xidi 50lution R md 02 mL ofsodium carbonate solution R Shalce with 1 mL to 2 mL of chlorofarm R and add l mL to 2 mL of rater R The clugraveoroform layer is ooloured red

b) Dissolve about 20 mg of the substance IO be examined or ilie ptescribed quantity in 5 mL ofacetic acid R Add 05 mL ofpotassium ferrocyanide salution R The s6lution renraillS citai Add abollt 50 mg of ammanium chlartde R A wliigravete ~tWJine ptetigravepitlite is futmed

CARBONATES ANO BlCARBONATES

Introduce into a test-tube 01 g of the substance to be examined and suspend in 2 rnL of water R or use 2 mL of theacute prescribed solution Add 3 mL ofdilute acetie acid R Clooe tlre tube inunediately using a stopper fitted wigraveth a glass tube bent twice at right angles The solution or the suspension becomes effervescent and gives off a colourless and odourless gas Heat gentIy and oollect the gas in 5 mL ofbarium hydroxide soution R A white precipitate is formed that dissolves on addition of an excess ofhydrochlaric acid RI

CHLORIDES

a) Dissole in 2 mL of water R a quantity of the sugravebstance lo be eacuteXamIgravened equivalettt to about 2 mg of clugraveoride (CI-) or use 2 igravetlL of the presccediltibed solution Acidify with dilute nitrigravec lCid R and add 04 mL ofsigravever nitrate solution RI Shake alld allow to stand A curdled white precipitate is formed Centrifuge and wash the precipitate with three quantities earo of 1 mL of water R Carry out this operation rapidly in subdued light disregarding the fad that the supematant solution may not become perfectly dear Suspend the precipitate in 2 mL of water R and add 15 mL ofammonia R The precipitate dissolves easily wigraveth tlre possible exeeption af a few large particles wIDch dissolve slowly

b) Introduce into a test-tube a quantity ofthe substance to be examined equivalent to about 15 mg of clugraveoride (Cl-) or the prescribed quantity Add 02 g ofpatassium dichromategrave Rand 1 mI of sulfuric add R PIace a filter-paper slrip iigravetJpregnated with 01 mL of diphenycarbazide solution R aver the opeiling of the test-tube The paper turns violet-red The impregnateli paper must not corne into oontact with the patassium dichromate

CITRATES

Dissolve in 5 mL of water R a quantity of the substance to be examined equivalent to about 50 mg of citric acid or use 5 mL of the prescribed solution Add 05 mL of sufurie acid R and l mL ofpatassium permanganate salutian R Warm unti the colour of the permanganate is discharged Add 05 mL of a 100 gL solution of 50digraveum nitroprusside R in diute sulfuric acid R and 4 g of sulfamie add R Make alkaline wigraveth concentrated ammonia R added dropwise until ali the sulfamic acid has dissolved Addition of an excess of concentrated ammania R produces a violet oolour tuming to violet-blue

EsttkS Ti) agravebolit lO mg 01 the substance to be examined or the ptesaibed qigravemtrtity add 05 mL of a 70 glL solution of hydfl1Xjitmiiife frydtochloride R in methano R and 05 mL of a 100 gL stilutibn l5fpatassium hydroxide R in ethanol (96 per Certt) R ~to bOiling 0001 acidify with digravelute hydrochloric add R tnl ltkl 02 inL offelrric ihlorid solution Rl diluted ten timeS A JjJigravedShregraved or red coloar is produced

fOOIDEgraveS a) Ot~lVe a ~tY of the substance to be examined eqliwlegravelIgravet to aIroUt 4 nig af iodide (I-) in 2 mL of water R or ~ 2mLoffltepregravescribed salution Acidify wigraveth digravelute nitric agravecUl R am add1)4 nil ofsilver nifrate solutian Rl Shake and alIdW to ~taml A curdled pale-yellow precipitate is formed CentiifiJglI and wash with tbree quantities each of l mL of watilr R Cagravetty out thigraves operation rapidly in subdued light disregarding tlre fatt that the supernatant solution may not become perfeacutectlr dear Suspend the precipitate in 2 mL of water R arigraved add 15 mI of ammonia R The precipitate does not dissolve

b) To 02 mI af a solution of the substance to be examined eacuteogravemlliItillg aboIit S mg of iodide (I-) per millllitre or to 02 mI ogravefme pr~lregravea s61ution add 05 mL of dilute sulfuric acid R 01 mL orptftugravelGlum dichromate solution R 2 mL ol water R aiJd 2 mL df cllltlrufotm R Shake for a few seconds and allow tl) stmd ffte clugraveogravetoform layer is ooloured violet or violet-red

IRON

a) Dissolve a quantity of the substance to be examined equivalent to about lO mg of iron (FeZ+) in 1 mL of water R or use 1 mL of the prescribed solution Add l mL ofpotassium ferricyanide solution R A blue precipitate is formed that does not dissolve on addition of 5 mL of dilute hydrochloric acid R b) Dissolve a qUatttity of the substance to be examined equivalent to about l mg ofiron (Fe+) in 30 mL of water R To 3 mL of this solution or to 3 roLof the prescribed solution add l mI of dilute hydrachlaric acid R and l mL ofpot~sium thlocyarrate soIatiiJh R The solution is coloured red Talce wo p6rtioos Itach al l mL of the mmure To one portion add 5 mL of itotfmyl akohol Ror 5 mL of ether R Shake and alIow to stalld The otgatrlc layer is ooloured pink To the other pottiogravell add 2 igravenL of mercuric chloride solutian R The red oolour disappears

c) Digravessolve a qUarigravetity of the substance to be examined equigravevalent to not less than l mg of iron (Fe3+) in 1 mL of water R or use l mL of the prescribed solution Add 1 mL ofpatassium ferrocyanide solution R A blue precipitate is futmed that does not dissolve on addition of 5 mL of dilute hydrachloric add R

LACTATES

Dissolve a quantity ai the substance to be examined equivalent to about 5mg oflactic acid in 5 mL of water R or use 5 mL of the prescrii1ed solution Add 1 mL of bromine water R and 05 mL of dilute sulfuric add R Heat on a water-bath until the calour is discharged stirring occasionally with a glass rod Add 4 g of ammonium sulfate R and mix Add dropwise and wigravethaut mtring 02 mL of a 100 gL solution ofsadium nitraprusside R in diute sulfuric acid R Stili without mixing add 1 mL ofcancentrated ammonia R Allow to stand for 30 min A dark green ring appears at the junction of the two liquids

LEAD

a) Dissolve 01 g of the substanee to be examined in 1 mL of acetic acid R or use l mL of the prescribed solution Add 2 mL ol potassium chromate solution R A yellow precipitate is forrned that dissolves on addition of 2 mL of strong sodium hydroxide soItttion R

See the information section on generai monographs (cayer pages) 120

~ugraveItOllEAtl PHARMACOPOEIA 80

h) lJissotve 50 mg of the substmce to be examitIed igraven l mI of atetic add 11 or use l mL of the presctihed solution Add lO m df water R and 02 mL ogravefpottusium icJdide Sdigraveitidn R A ycllogravew predpigravetate igraves formed Heiigravet lo hltlilfug for l min tb 2 min The precipitate diampsolves Alldwto couI The pt~t1ite iSre-fc1trtied llS gliStegravefiigraveng regravelldw plates

MAltJNESruM Dlliltnlvegrave abiUt 15 rog of the sUbstanCegrave ID 11e ~ed in 2 mL oi watlr R or ugraveseacute 2 m ai the pfescfil)ed solUtion Add l ttigraveL af d11utegrave ammogravelia RI A white precipitate is formed that dissalves on additinn of l mL of am1ndilium chlarde sdlUtian R Add l m ()f disodiU1n hydrogen phosphategrave soution R A white crystalline precipitate is fonned

MERCURY a) PIace about 01 mL of a solution of the substance to be eliamined on well-scraped copper foiI A dark-grey staigraven that bigraveromes shiny on rubbing is formed Dry the foil and heat in a tes1-tube The spot disappears b) To thepttsctibed soligraveltionaidddiute Miigraveuffl hydtoXide SlJtllttlQn RUJ1tll sfigraveOtigravegly aIkaIirte (224) A degraveDse ye1lffW ptecipitate igraves fotligraveigraveed (mercutic salts)

NITRATES To a mixtute ofOl m of f1itrobeniene R and 02it1L oi sttlfurie acid R add a quantity of the powdered substmce equivalent to about 1 mg of nittate (NO) or the prescri11ed quantity Allow to stand for 5 min Cool igraven iced water and add slowly md with mixing 5 mL oi water H then 5 mL oC strong sodium hydroxide solution R Add 5 m oC acetone R Shake md allow to stand The upper laya is coloured deep violet

PHOSPHATES (ORTHOPHOSPHATES) a) To 5 mL of the presctibed solution neutra1isegraved iineteS1igraveigraveugraveY add 5 mL ai siver nitrate solutigraveon Hl A yellow Ftecipitate is formed whose colour igraves nm changegraved by boilittg and which dissolves on addition ofammonia R b) MiX l mL of the prescribed solution with Z mI oC molybdovanadic reagent R A yellow colougraver dev-egravelops

POTASSIUM a) bissolve 01 g of the substance to be examined in 2 mL of water R or use 2 m oi the prescribed solution Add l mL oi sodium carbonate soution R and heat No precipitate 1S formed Add to the hot solution 005 mL of sodium sulfide solutlofl R No precipitate is iormed Cool igraven iced water and add 2 mL of a 150 glL solution of tartarie acid H Allow to stando A white crystalligravene precipitate is formed b) Dissolve ahout 40 mg oCthe substance to be examined in 1 mL of water R or use 1 mL of the prescribed solution Add l mL of dillte acetic acid R md 1 m of a fremly ptepared 100 gL solution of sodium eabaltinitrite R A yelldw or orange-yelJow precipitate is formed immediately

SALICYLATES

a) To l mL of the prescribed solution add 05 itlL oCferric eharide solution RI A violet colour igraves produced that pegraverSists afta the addition of 01 m of acetic acid R b) Dissolve 05 g oi the substance to be examined in lO m of water R or use lO mL of the prescribed solution Add 05 mL of hydrochoric acid R The precipitate obtaigravened after recrystallisation from hot water R and drying in vacuo has a melting point (2214) of 156middotC to 161 middotC

SILlCATES

Mix the prescribed quantity of the substance to be examined in a lead or platinum crucigraveble by means of a copper wire with about lO mg of sodium fluaride R and a few drops of sulfitric acid R to give a thin slurry Cover the crucible with a thin transpatent plate ofplastic unda which a drop of wl1tegraver R iigrave suspended and warm gentIy Within a short time a white ring 1S rapidly formed around the drop oi water

Generai Notices (1) appy to ali monographs and other texts

131 ld~tiGll reactions of ions and functional groups ~

SIl~

~lveagravebttot 10mgofthesubstanceto beexamined in 10m gi wiegravet ROgraver~1 O itIL of the prescribed solution Add 03 mL cjf igravetjdrliegrave11lVrie Ilcill RI A curdled whlte precipitate is formed thatdiSSdlveacuteS~ob addItion 00 m oi diute ammonia RI

sonigravelM a) bisro1veOgrave( g or the sllbstance to be examined in 2 m of wiLttit R digrave ~~2 mL of the prescribegraved solution Add Z mL ai a ISO fIL salutlon ofpotassium carbonate R and heat to bdilfug NegraveI ~dpitate is formed Add 4 m ofpotassium pyrograveantimlihme sOution H and heat to boillng Allow to eool igraven iced wttet and iineegraveessary rub the inside of the test-tube with a pSs rodo A dense white precipitate i5 formed

b) Dissolve a quantity of the substance to be examined equivalent fo aoougravet 2 mg of sodium (Na) igraven 05 mL of wateT R OT use 05 mL of the presctibed solution Add 15 m of methOXJ1lhenylacetic reagent R and cool in ice-water for 30mm A volligravetcugravebdns white crystalline precipitate is formed li1iIie ili ~ atZO middotC md stir ior 5 mm The precipitate ~dms ilot~ Add 1 m of dilute ammonia Rl The pre-lpigraveWeacute ~dlSliOIYeacutes eOIigravelplete1y Add l mL oi ammonium carbonate togravelufidn R No precipitate is formed

SULFATEgraves

a) DissolVe about 45 mg of the substance to be examined in 5 m of Wl1ter R ot use 5 mL of the prescribed solution Add l mL of dilute hydrochloric acigraved R and l m ofbanum ehloride soution RI A white precipitate is formed

b) To the suspension obtaigravened during reaction (a) add 01 m ai 005 M iadine The suspension remaigravens yellow (distinction from suliites and dithionites) but is decolorised by addigraveng dropwise stannIJus ehloride solutigraveon H (distinction from iodates) Boil the mixture No coloured precipitate i5 iormed (distiilction frtlin selenagravetes and tungstates)

TARTPATBS a) Dissolve abGut 15 mg ogravef the substance to be examined in 5 mL ofwMer Ror use 5 mL of the prescribed solution Add 005 mLof a lO gIL solution offerrous sulfate R and 005 mL of dllute hydragen peroxide soution R A transient yel10w colour igraves produced After the colour has disappeared add dilute sodium hydroxide solutigraveon R dropwise A violet or purple colour is produced

b) To 01 m oI a solution oi the substance to be examined contaimng the equivalent of aoout 15 mg of tartarie acid per millilitre or to 01 m ofthe prescribed solution add 01 mof a 100 gIL solution oipatassium bromide H 01 mL of a 20 glL solutiogravell of r~cigraveno R and 3 mL of sulfuric acid R Heat on a water-bath filt 5 min to lO min A dark-blue colour develops Allogravew to c601 md paur the solution into water R The colour changes tu red

XANTHINES

To a few milUgtatns oi the substance to be examined or the presctibed quantity add 01 mL oi strong hydrogen peroxide solutigraveQfI H md 03 mL of dilute hydroehlorie acid R Heat to dtyness on a water-bath until a yellowish-red residue is obtaigravened Add 01 mL of dilute ammonia R2 The colour of the residue changes to violet-red

ZINC

Dissolve 01 g oi the substance to be examined igraven 5 m of water R or Use 5 mL oC the prescribed solution Add 02 m ofstrong sodium hydroxide soutian R A white precipitate is iormed Add a further 2 mL oi strong sodium hydroxide solutloll R The precipitate dissolves Add lO m oC ammonium ehloride solulion R The solution remaigravens dear Add 01 m of sodium Sugravefide sograveution R A tloccu1ent white precipitate is formed

121

1 GeneraI notices

SolUbilitY In stategraveItlent~ of solubigravellty in ili C1ruigraverctets seit1ogravefi ilieacute teacuteIDls used haVe me fograveUowmg sigrugravelicance refmtd to a temperlitUre begraveeieegravefi 15 middotC md 25degC

Drui~ tegravel1i1 ~8teo1mtleacuteofs)~m~

~wwlugraveu VKiltlbll lesi tbm

Fteelysograveluble [rom tb io

SoInhle froln lO to 30

Sparlngly soIuble from 30 to 100

Slightly soIuble from 100 to 1000

Very sligligravetly soluble from lOro tu 10000

Practiclilly igraveilSolUhle more Igravean 10000

1hegrave term partly solublegrave is USed to desCribe a miXt1lre ~ Ohiy some of the egraveomponeots disscigravegte The tett11 misdble ili ugravesed to dextibe a liquid that is miscible in al propottiotls With the stltted sovent

IDENTIFiCA TI0N Scope The tests giVegravetl in the Identification seeacutetIgraveun ate fiOt designed ID give a full confirmagravetioIgravel of the chetnical sttucture or composition of the producti they are intended to give confirmation with an acceptable degree of assurance that ttle article conforms to the description on the label

First and second identifications Certain monographs have subdivisions entitled First identification and Second ideotificatiOIL The test or tests that constitute the Figraverst identification may be used in ali drcumsrances Tbe test or tests that conStitute the Second identilication may be uscd in phannades provided it can be demonstrated that the slbstance or preparation is fuIly traceablegrave fo a batch eacuteertifred to compIy with ali the other requiretnents ogravef we monogrtph

Certain monographs give MO or more set5 of tests fur the purpose of the first identification which are equivalegravetlt and may be used independently One or more of these sets usualIy contain a cross-reference to a test prescribed in tbe Tests section of tbe monograph It may be used to simplify tbe work of tbe analyst carrying out the identification and the prescribed test5 For example one identification set cross-refers to a test for enantiomcric purity while the otber set gives a test for specific optica rotation the intended purpose al he two i5 the same that is verification that the correct enantiomer is present

Powdered herbal drugs Monographs on herbal drugs may contain schematic drawings of the powdered drug These drawings complement the description gigraveven in tbc relevant identification test

TESTS AND ASSAYS

Scogravepe The requirements are not framed to tm aCCGunt of1ugrave1 possible impurities It is not to be presumed for examplegrave that an impurity tbat is not detectable by means of the presaibegraved tests is tolerated if common sense and good pharmaceutica practice require that it be absent See also below under Impurities

Calculation Where the result of a test or assay is required to be caculated with reference to the med or anhydrous substance or on some other specified basis the determination oflos5 on drying water content or other property is carried out by the method prescribed in the relevant test in the monograph The words dried substance or anhydrous substance etc appear in parentheses after the tesult Where a quantitative detertnination of a residual solVent is carried out and a test for 10ss on drying is not carried out the conteot of residual solvent is takeo futo account for the calculation of tbe assay content of the substance the spegravecific optical rotation and the specific absorbance No further indication i5 given in the 5pecific monograph

EUROPEAN PHARMACOPOEIA 82 ---~

LiinhsTfre Igravemits ptescribed are based on data obtained ilimftriagravelifialyutal lraetice they take account of normal atial1tilta1f lifr~ ltlf aCcegraveptagravebIe variations in manufacture and egravetlffIl~md df deterioration to an extent considered agraveeceptabigravee NOfuttber toletances are to be applied lo the limits pregravesditiet1 todeteigraveminewhegravether the artide being examlned c~rresWigravetli dte requitements of the monograph In deteItIgraveiiilirg cotnpliance with a numericalllinit the cUgrave~ teacuteSUgravetogravef a test or assay is first rOWlded to the number fJ( silfificant figures srated unless otherwise presttibed The limin regardless ofwhether the values are exptessed agraves pettentages or as absolute values are considered significaigraveigravet fu the last digit shown (for example 140 indicates 3 stgnificantfigates) The last figure of the result is increased by ogravene when fhe pm rejected is equal to or exceeds one half-unit Wbereas it isItOt modified when the part rejected is less than a JWf~Wigraveit

lbdlagraveif1eacuteJigrave1bf]fermigraveltid limit of impurities The acceptance Criteria fot tIeacutelagravetetl substances are expressed in monographs eigraveth~ ili teftfis (jf cdmparison ofpeak areas (comp arative tests) or as ttiln~ti(1d values For comparative tests tbe approximate cofitent of impunty tolerated or the sum of impurities may be indicared in brackets for information only Acceptance or rejeCtiotl lS determined on the basis of compliance or non-compliance with the stated test If the use of a reference substance fCfr tbe named impurity is not prescribed this content may be expregravessed as a nominaI concentration of the substance used to prepare the reference solution specified in the moIWgIigravelph unless otherwise described

Herbal dnrgs For herbal drugs the sulfated ash total ash watet-sohlljlegrave matter alcohol-soluble matter water content comeacuteligravet ogravef egraveSilntial oil and content of active prindple are calcugrave1atedwigraveth teference to the drug that has not been spedally dried unless otherwise prescribed in the monograph

Equivalertu Where an equivalent is given for the purposes of the fgtharmacopoeia on1y the figures shown are to be used in applying the requirements of the monograph

Cultute media The culture media described in monographs and genernl chapters have been found to be satisfactory for the inteilded purpose_ However tbe components ofmedia particulatly those of biologica origino are of variable quality and it may be necessary for optlmal performance to modulate ilie concenttation of some ingredients norably

- peptones and meat or yeast extracts with respect to their nutritive propetties

- buffering substances - bile sillts bile exttact deoxycholate and colouring marter

depending art their se1ective properties

- ailtibi(jtia with respect to their activity

STORAGE The information and recommendations given under the heading Stotage do not constitute a pharmacopoeial requirement but the competent authority may spedfy particular stotage conditions that must be met

The artides described in the Phannacopoeia are stored in such a way as 10 prevent contarnination and as far as possible deterioratigraveon Where spedal conditigraveons of storage are recommended induding the tYPe ofcontainer (see sectlon 13 Genera chapters) and limits of temperature they are stated in tbe monograph

tbe folloWfug eXpressions are used in monographs Wlder Stotagravege Wigravetb the meaning shown

In ah aitttgnt conhtiner means that the product i5 stored in an airtight contagraveiner (32) Care is to be taken when the container is opened fu a dail1p atmosphere A low moisture content may be I1laihtained ifnecessary by tbe use of a desiccant in the container provided that direct contact with the product is avoided

Sa the information senon on generai managraphs (caver pages) 3900

Sodium salicr1ate

StUfatn (2413) matiJhmn 3lJO pptn fo 25 triI of sugravelution S agravedd 5 fiL iif diin11~d waiegraveTR 3M 10 mL of k)droehloric adii R md dilute to 50 IfiL Wigraveth dtstiltelIgrave water R Shake and tuter Dilute 10 mL Of the filtrltte to 15 mL with distifled wattr R

Heavy metw (248) maximum lO ppm 20 g COrllplies with test C Prepare the refcrence solutigraveon usmg 2 mL cf lead standard solution (10 ppm Pb) R Water (2512) maximum 50 per cent determined on 0~500 g

ASSAY

Liqllid chronigraveatbgrapby (2221) agraveS destrlbed in tre restfar teated substances With the fuUoMhg moedmcmograven

lnjlctiograven teSt solutiOh agravetld rderelteacutee solution CB) Calcu1ate the petcentage content of CrJ111Na03 (rom the dedared content ofprr1p)1 pamhydrdt)ltenzograveategrave CXS multiplied by a correction factor Of 1122

STORAGE In an airtight container

IMPURITIES specified impurities A Other detectable implltities (the fallowing sul1stance$ wotugraved ifpresent at a sufficient level be detected by aIle or ogravether of the tests in tbe monograph They are limited by tbe generaI acceptanccedile criterion for otberunspecified impugraverities andJor by the generaI monograph Substances far phatmaceuliegraveal ust (2034) It is therefore not necessary to identify tbee impUlitieS for demonstration of compliance See also 510 Control d impurities in substances for pharmaceutical use) B C D

HOUgrave~H A 4-hydroxybenzoic acid

o

HOdo-CH3 B methyl4-hydroxybenwate (metbyl parahydroxybenzoate)

o

HOdO~CI-l3 C etbyJ4-hydroxybenwate (etbyl parahydroxybenzoateacute)

ograve

HOdo~~ D butyl 4-hydroxybenzoate (butyl parabydroxybetlwate)

0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

DEFINITION Sodium 2-hydroxybenzenecarboxylate

BUROPEAN PHARMACOPOElA 80

cQlttiIgraveIgraveltsect9Ogravepeigrave cent to 1010 per cent (dried substanccedile)

C~G1iRS APJIegravelUflntewlifte or almost whlte crystalline powder or SrtIldI cegravelldugraverlegravess ctystals or shiny flakes SugraveIuftiigravelt frtegravely soluble in water sparingly soluble in etbanol (96 per cent)

lDENTIFiCATION fifrst ide1IgravetljitigravetiofI A C Setrmd iaenfijicatiiJn B C A fnfrared aampotptiograven spectrophotometry (2224)

CagravemJ1(Jri~d1I sodiuffl saZicylate CRS B Sd1tiddn S(Ste TegraveSfs) gives the reactions of salicylates

(23f) C Ii g~ reltflon (b) of sodium (231)

1ESTs Soli1tion S DiSSOlve 50 g in carbon dioxidefree water R prepared ftom digraveStilled water R and dilute to 50 mI with the same salVent

AppeatInCc af$l))lltIgraveoll Solution S is dear (221) and not more intemely coloured than reference solution BY6 (222 Methad 11)

Aegraveidity TIgt 20 mI of solution S add 01 mL ofphenol red solmiun R the smiddotolugravetion 1S yellow Not more tban 20 mI of 001 M iatltum hydroxide is required to change tbe colour of tlie illdiltttor to vlollft -red

Cbldrldes (244) lnmmum 200 ppm To 5 mI ai sulutIgraveon S add 5 mL of water R and lO mI of diute mtric add R attd flltet Dilute 10 mL oftbe filtrate to 15 mI with water R

Sulfates (2413) magraveXimum 600 ppm Dilute 25 mL of solution S to 15 mL With distilled water R

Beavy metals (24_8) maximum 20 ppm Dissolve 16 gin 16 mL of a mixtUre of5 volumes of water R and 10 volumes ofethanol (96 per cent) R 12 mI of tbe solution ccedilomplies with test B Prepare tbe reference solution using leali standard solution (2 ppm Pb) obtained by diluting lead standard solution (100 ppm Pb) R with a mixture of 5 volume of wa1er R and lO volumes ofethanol (96per cent)R

1055 Oil dtyugravelg (2232) maximum 05 per cent determined on 100 g by dtying in an oven at 105 middotC

ASSAY Dissolve 0130 g in 30 mL of anhydrous acetic add R Titrate with 01 M pmhomiddotric add determining tbe end-point poteacuteritio~y (2220) l mI cf 01 M perchloric add is equivaIent to 1601 mg of C7HNa03bull

STORAGE In aD airtight container protected from light

0120081677

SODIUM SELENITE PENTAHYDRATE

Natrii selenis pentahydricus

M 2630NazS1iideg3ffiO r (26970-82-1]

DEFINITION Content 985 per ccedilent to 1015 per cento

CHARACTERS Appearanee white or almost white crystalline powder hygroscopk

Set the irtfarmation secnon on generai monographs (cover pages) 3264

EUROPEAN PHARMACOPOEIA 80

- impurity C Dot more than the area of the rorresponding peak in the drrotnatogram obtalrred With referlnce sollltigraveon (O (002 per cent)

- any 6th impurity for em hnputity ttot mogravere than tbe area ofme peak due to inigraveputity 13 in the tHiotbaftlgtlittl obtainedwlth refdente sogravelutron (f) (0Ograve5 pd cmt)

- togravetal not more than ooce the area of the pegraveak dUe to impugravelity A in the chfomatogrllin obtained wim teftetigraveegraveeacute solutiltigraven (f) (02 per cent)

disregard Utnit 001 tIgraveInes the area Of thl prfucipal pegraveakih the chromlItogtanl obtained wlth tefeterice $Olugraveti6n (f)

Chlotides (244) maximum 100 ppm

Dilute 10 niL of solution S to 15 niL wlth water R

Sulfates maximum 200 ppm

DissolVe LO g in 5 mL ofdimethrlfortnatnide R and add 4 rilL of wateT R Milt thoroughly Add 02 mL of dilute hydToeacutehlUric acid R and 05 mL of a 25 per cent mm solugravetion of bariUtn ehlaride R Afler 15 rnin any opaleacutestence in the solution is amplt more intense than that in a standard prepared as folloWs to 2 tnL of sulfate stllndard salution (100 ppm SOJ R add 02 tnL of dilute hydrochlaric add R 05 mL ogravef a 25 per Clnt mth solution of barium ehlaride R 3 mL of water R and 5 mL oi dimethylformamide R

Heavy metals (248) maximum 20 ppm

Dissolve 20 gin 15 mL of ethanol (96 per cent) R and add 5 mL of water R 12 mL of the solution complies Wl1h test B Prepare the reference solution using lead standard solutiort (2 ppm Pb) prepared by diluting lead standard solution (100 ppm Pb) R with a mixture of 5 volumes cf water R and 15 volumes cf ethanol (96 per cent) R

LOS5 OB drying (2232) maximum 05 per cent detettnihed on 1000 g by drying in a desiccator

Sulfated ash (2414) maximum 01 per cent detegravelInined ograven 20 g

ASSAY

Dissolve 0120 g in 30 mL of ethailol (96 per cent) R md acd 20 mL of water R Titrate with 01 M sodium hydroxide using 01 rnL ofphenol red solution R as indicator

1 mL cf 01 M sodium hydroxide i5 equivalent to 1381 mg ofCHO

STORAGE

Protected from light

IMPURITIES

Specified impurities A B C

rocugrave~ A R = H 4-hydroxybenwic acid

B R COH 4-hydroxyisophthalic aCid

(JOH C phenol

Generai Notices (1) apply to ali monograplts and othet teXs

S8lrneterolxinafoate

0120081765

SAtMETERUgraveL XINAFOATE

SaID1etetoli 1dnafoas

~=~ HO(9COtH~~0 ~o) OH~ agraveigravelU~

CH4iND MT 604 [94749-08-3]

DEFINIrtON

(lRS)-l- [4-Hyigravertlxy-3(Hydroxymethyl)phenylJ-2-[[6-(4-phen1fbttwxy)liMyigrave] lmifiolethanol1-hydroxynaphthaleneshy2-tiDboxylate

CCtfltellf 970 per ccItt ti) 1020 per cent (anhydrous substance)

CHARActERS Appltatl1nte whitigravei or almOS white powder

SblubiliW Dtlfegravetitally insogravelugraveble in water soluble in rnethanol in anhydrograveugraves ethanol

DENtIFICAnON Infrared abstrrption spectfophogravetometry (2224)

CompatisQn sagravelmetertJl xinafoate CRS

TESTS Related sllbstafices Liquid chromatography (2229) Protect the solutions jrdtfllight SolvrntmiXtute aagraveftfllitfilegrave R water R (5050 VV) Test sagravelutiiin DiSsolve 500 rigraveig of the substance to be examinegraved in the solvem tniXtUre and dilute to 100 mL with tlre solverit miXlUte Riferrnce 5oliti(in (a) Dissolve Il mg of salmeterol xinafoate for system suitllb1lity CRS (sagravelmeterol containing impurities E md G) in tbe solvent fligravelXtUre and dilute to 2 mL wlth the solVeDt miXture Reference solution (b) Dilute 10 mL of the test solution to 1000 mL wlth the solvent mUt1lre Dilute 10 mL of this solution to 100 mL with the solvent mixture Column - size l = 015 ID (2) 46 mm

- stagravetionary phlaquose octadecylsilyl silica gel for chtomawgtltphy R (5 tIffi)

Mobile phase - mobile phtiSegrave A mft 24 volilriles of a 771 glL solution

of ammonium acetati R with 24 volumes of a 2884 gIL solution of sodium dlfdecyl sufate R and adjust to pH 27 wlth gladal acetic acid R mix with 52 volumes of acetonitrile R

- mobile phase B aeetonitrile R

Time Mobile phase A Mobile pheB (min) (jrer cent VI (Eerent VIV)

0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O

Flogravew rate 2 tnlJrnin

lJltection spectroplrotol1leter at 278 nm

Injectiofl 20 fiL inJect the solvent mixture a5 a blank solution

3199

Sagravelkylic ~id EUROPEAN PHARMACOPOEIA 80

SagraveIUbiift) slight1y solubie in water freely soluble in ethanolo n)(~ (96 per celJt) sparmgly soluble in methylene chIoride

llQ HoC CH IDENTiFlCAI1OgraveNif

lOlt J 2c [ (ll-dimetlfylegravetliylamino]-1- [4-tdltfxy-3shy

(hyQroxymethy1)ptrenyl]etlwiofie (siIgravelbUtltmoile)

CIccedil0deg it(XC~ HO H~ ~

OH

K 2-[(11dimethylethyl)amino ]-1-[3-cligraveloro-4-hYdr0llY-5shy(bydroxymethyl)phenyl]cthanone

ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011

L (lRS)-2-[(ll-diigravenethylethyl)amino]-1-[3-CbldtlY-4shyhydroxy-5-(hydroxymethyl)phenyl]ethagraveiJol

~nXC~ HOlCIi~ HC ~ end~

oCIi~

M (IRS)-2-[(1 l-dimethylcthyl)amino ]-1- [4-hydrQxy-3shy(methoxymethyl)phenyl]ethanol

VOI ~ clia

r bull (-CH 00 ooCHa

li NXCils

liQN 0 Cfi

lOH N 2-[(ll-dimethylethyl)amino]-1- [3- [[5- [2- [(11shy

dimethylethyl)amino]-1-bydroxyethyl]-2-hydroxyshyphenyl]methyl]middot4-hydroxy-5-(hydroxymethyl)pheacutellyl]shyethanol

o unknown structure

bull 01lZOO80 eorreacuteeted 60

SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r

DEFINITION 2-Hydroxybenzenecarboxylic acicl Cimtent 990 per cet1t to 1005 per cet1t (dried s~tmce)

CHARACTERS

Af1Pearance white or almost white etystagraveHne pljWder or white or colourless acicular crystlUgraves

3198

FrritidmtifiCflfj(m A B Seaifldittefltfoettiim A C A Mlltiilg ptiIgravellt (2214) 158 middotC to 161 cc B lnfraietl absurption spectrophotometry (2224)

eacutetJlnpiitwn sagravelicyic acid CRS C D1SSeacutelIife agravebout 30 mg in 5 mL ol 005 M sodium hydroxide

Igrave1eacuteutnlise ifnecessary and dilute to 20 mL with water R 1 mL 1f the rolution gives reaction (a) of salicylates (231)

TssrS

Solugravetion S Dissolve 25 gin 50 mL ofboiling distiUed water R 0001 and filtegraver Afitreagraverlrnce (jf sblution The solution is clear (221) and egraveugravelolldess (222 Method m Dissole 1 g in lO mL of ethrmol (96 per cent) R

Rclategraved mbstagraveDces Liquid chromatography (2229)

Tegravest sogravelutiun Dissolve 050 g of the substance to be examigravened ID die mobile lbase and dilute to 1000 mL with the mobile pbase Rltfotrttegravee solution (a) Dissolve lO mg ofphenol R (impurityC) in the mobile phase and dilute to 1000 mL with the mobile phase

Referenceacute sogravelution (b) Dissolve 5 mg of salicyic acid ifnputity B CRS in the mobile phase and dilute to 200 mL with tbegrave mobile phase

Reference soution (c) Dissolve 50 mg of4-hydroxybenzoit acid R (impurity A) in the mobile phase and dilute to 1000 mL with the mobile phase Reference solution (d) Dilute LO mL ofrefcrcnce solution (a) to 100 mI with the mobile phase

Refotegravence solutiograven (e) Dilute a mixture of 10 mL of each of referegravehce solutions (a) (b) and (c) to 100 mL with thc mobile phase Riferente 50lUtion (f) Dilute a nllxture of 01 mL oi each of refereilce 501utions (a) (b) and (c) to 100 mL with tbe mobile phase

Column - size 1= 015 m 0 =46 mm - stationary phase non-deactivated octadecysiyl siica gelfor

chromatography R (5 J1m) Mobile phase glacia acetic add R methano R water R (14060 VVV)

Flow rate 05 mLmin Detection spectrophotometer at 270 nm l lO L fth l d _c l (d)nJection Il o e test so ution an r1crence SO utions (e) and (f) Relative retentiograven with reference to impurity C impurity A =abom 070 impurity B = about 090

System suitallility reference solution (e) - the 3N peak in the chromatogram corresponds to the peak

due to phenol in the chromatogram obtained with reference solution (d)

- resolution minimum LO between the pcaks due to impurities B md C ilnecessary adjust the quantity of acetic add in the mobile phase

Ligravemigravets - jt1lpurity A not more than the area of the corresponding

peak in the chrotnatogram obtained with reference solution (f) (01 per cent) tmpurlty B not mOre than the area ofthe corresponding peak in the cbromatogram obtained with reference solution (f) (005 per cent)

SeI the information section on general monographs (cover pages)

Diphellograveqlltte llydtbdUotidegrave

pligrave~ Dillite 20 fuL of thegrave Sogravelution to 1OOIfiL Witb me mobileph~

Refetence routidn (a) bilme 10 tnL ogravef the tt 5ograve1utlon 10 100 mL With tbemogravebigravele phage Digravelute 10 mL oftltis Sollrtion to 200 mL wigraveth tbe mobile ph~ Reforence solutWn (b) Dissolve 5 mg of diphlnhyugraverafriifre impugraverny A CRS and 5 mg ofdiphenylinethatfol R in tbe mobile phase aIld dilugravete to 100 mL With thc mobile phase lO 20 mI of this solution add 15 mL of thc test solution and dilirte to 100 mL Witb tbc mobile phase Column

size l 025 ID 0 46 mtn - staticmaty phase firise-degraveaeacutetMted 61tylsujll silIgraveigravea griI for

chroflUlffgtliphy R (5 IDl) Mobile p1tase illiX 35 VogravelUtt1es of acrftograveigravelitnlegrave R aitd 65 VI)Iugravellie-s of a 54 gIL sogravelugravetitm ogravefpotllStiugravem dihjdrogen phospktttegrave R adjugravested fo pH 30 using phasphiJtie add R FliJW rate 12 mLmin Detection spectr6photOmcter atnO Ifitl Injection lO J1L Run rime 7 times the retention time of diphcnhydrnlnine Relative retention witb reerence lo diphenhydramine (retentigraveon timc = about 6 min) impurlty A = about 09 impurity B = about 15 impurity C about 18 impurity D =about 26 impurity E = about 5L System suitaliility refercnce soluti6n (b) - resolutian migravenitDUm 20 bctWtleIl tbe peaks due to

diphenltydtamigravene and to impurity A Limits - correcffan factor for the calcugravelatioograve of content mulftply

the peak uca of impurity D by 07 - imputity A not more than the uea of the ptindpal pealeacute

in thc chromatogram obtaigravened with reference solution (a) (05 per cent)

- any other impurity not more than 06 times the area of the principal peak in tbc chromalogram obtained with reference solution (a) (03 per cent)

- tatal not more than twice the uea oftbe principal peak in tbc chromatogram obtained with reference solution (a) (10 per cent)

- disregard limit 01 times the area of the prillcipal peagravek in tbe chtomat6gtam obtaigravened with reference solution (a) (005 per cent)

Los50n dtying (2232) maximum 05 per cegravent deteimineli on 1000 g by dryigraveng in an oven at 105 C Sulfated ash (2414) maximum 01 per cent determirted ort LOg

ASSAY Dissolve 0250 g in 50 mL of alcoho R and add 50 IiigraveL of 001 M hydTochloric adti Carry out a potentiometnc tigravetration (2220) using 01 M sodium hydroxide Read thc volume added bctwccn the 2 points 6f inftexion l mI of 01 M sodium hydroxide is equivalent to 2918 mg of C7H22ClNO

STORAGE Protected from light

IMPURlTIES Specified impurities A B C D E

R f ~ nd~

R

gz0-- CHa

A R R =H 2-(diphenyimetboxy)-N-metbylethaigravelarnigravene

troItoPEAN PHARMACOPOEIA 80 ct~ C) t

B R R == cR32Cr(~c(41iIithylphenyl)phenylmethoxylshyNN-~le-tha1Xllitilligraveeacute

C R Br R =CfI~ 2-[(RS)-(4-bromophenyl)phenylshymethoXyl-NN-~ethanamigravene

J D R OH R H diplfegravel1yImetbanol (benzhydrol)

Eacute Il +R= OampplJeiigravey~mone (benzophenone)

0420120819

DIPliENOXYLATE HYDROCHLORIDE

Diphegraveugraveoxylati hydrochloridum

oQ~O OeH

~ilA~ClN20Z M4891 [3810808]

rmFOOnON EtHyl lmiddot(3middotcyaITo~33-diphegraveograveylptopyl)-4-phenylpiperldineshy4-catboXJlate Iiydrochlotlde CohttHt 9amp0 per cent fu 1020 per cent (drled substance)

CHARActElS Apf1eattmce wliite or almogravest white crystalline powder Solugraveiility Very slightly soluble in water freely saluble in methylegravene clil(jtide sparingly saluble in etbanol (96 per cent)

IDENTIFICAX1ON A IntYared absdtptiigravem spettrophotometry (2224)

Cdmytlfistm dipTt~lttte hydrOehotide CRS B D~owe abograveUt J(J iitg in 5mI of methanol R Add 025 mL

ogravef nltrie add R md 04 mL of Silver nitrate solution RI Shake and agravellow to stando A cugraverdled precipitate is formed CeIltrifugeacute md tinse the precipitate witb 3 quantities each of2 mL or nlet1uanal R Cury out tbis operation rapidly and protected ftogravem bright light Suspend the precipitate in 2 mL of water R md add 15 mL ofammonia R The precipitate dIssogravelves ell5ily

TEStS

Appeartthee df igravejolotion the solution is dear (221) and not more iIltensely coloured than reference solution Y6 (222 Method1I) Dissolve 10 gin meacutethylegravene chlaride R aIld dilute lo lO mL With thc 8igraveIigravel1e sogravelVegravent

Related SugravebStlInces Liquid chromatography (2229)

Sagravelution A Adjust 900 mL of water R to pH 23 with phosphoric acid R aiId dilute to 10000 mL With water R Solvertt mixtute aceacutetimitrilegrave RI solution A (5050 VV) Test solution Dissolve 25 mg of the substance lo be examigravened in 20 mL o tbe solvent nilirture sonicate for 2 min cool and dilute lo 250 mI With the solvent mixturc Referenee salutWn (a) Dl1ute 10 mL of tbe test solution lo 1000 mL with tbe solvent miXture Dilute 10 mI of thigraves solutigraveon to 100 mI witb tbe sogravelvent mUture

Sa the information secffon ograven general monographs (cover pages) 2074


~ impuri F not mcrrethcan 06 timeacutestheltteadftMptiridpugrave I1egraveak ili the clltotttatoffram ogravelifaifled fih mmigraveigravece foution (h) (3 per cmt)

- arigravey othtr imputity not milre tllm 02 tfrhes theagraveteagraveof the prilicipal peak in iliegrave chromatogtam oJjtigraveugravelled With refetenee solution (b) (l peT cent)

- total ojother impurities and imputity A not more thah 02 times the area oithe principaIpeak in the drtogravematognm obtained with reference sogravelution (b) (l per Cetlt)

- total not more than twice the area of the pTincip-al peak in the chromatogram obtained with reference soltition (b) (lO per cent)

- disregatd ligravefflit 002 tilIlegraves the area of theacute principalPeak in the chromattlgrtm obtaitied With teacutef~eacuteegrave $oltttmligrave (b) (01 per cerigravet)

He-avy metals (248) matilttllm io ppm 20 g COlfipUes With test C Pteplllethe nfigraveffreacuteegrave solutiograveil tismg 40 mL of lead standl1rd rol1itf111 (la pptn Pb) R Water (2512) malCIgravemum 60 per cent d~egravetlIgravelinegraved ograven OjOYl g Sulfated ash (2414) mamnum 02 per cent deacutetermineacuted oD 10 g

ASSAY Liquid chromatography (2229) as described in the test for regravelated substances Injection test solution and refetence silution (a)

stORAGE In an agraveittight cCigraventainet

IMFURtrms

o~shyCH

A 1-(3-hydroxy-4-methoxyphenyl)ethanone (a(etoisovanillone)

~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O

B (2S)-7-[[6-0-(6-deoxy-a-L-magravetiUeacutepyrattosylH-n glucopyranosyl]oxy]-5-hydtoxy-2-(3-hydtoxy-4shymethoxyphenyl)-23-dlbydro-4H-l-benzopyran-4-bne (hespmdigraven)

1101b~R1R2B 00 o HOHO OH l

HO R3

OH OH o

C Rl R3 = H R2 = OH 7-[[6-0-(6-deoxy-agrave-Lshymannopyranosyl)-~-D-gltiCdp)randsylloxyl-5-hydmXy~lshy(4-hydroxyphenylHH-l-beacutenUipyran-4-ane (i~otIrOifolin)

D Rl = OH R2 OCH3 R3 = I 7-[[6-0-(6-dooxy-a-Lshymannopyranosyl)-~middoto-glucopytanosyl)egravelXy) -5-hyclroxy-2shy(3-hydroxy-4-inethoxyphen5l)-6-iodil-4H -1-beacutentogravepyrat 4-one (6-igraveodo-digraveogravesmUgraveJ)

E Rl = R3 = H R2 = OC~ 1-[[6-0-(6-deoxy-a-Lshymannopyranosyl)-~-D-glucopyrmosylJoxyJ-5-hydroxy-2shy(4-methoxyphenyl)-4H-lmiddotbenzopyran-4-one (linarin)

GeneraI Notices (1) apply to all memographs and Mher ttXts

Diphenhydramine hydrochloride

kli

Ogravef O

F 51j dibydtoXy-2-(3-hydroxy4-methoxyphenyl)-4H-lshybettzopyrah-4-one (diosmetin)

0)20080023 corrected 60

DIPREgraveNHYDRAMINE HYDROCHLORIDE

Digravephenhydramini hydroch1oridum

J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]

DEFOOtrDN 2-(Diph~tileIlroX)-NN-digravemethylethanamine hYdftldllOritle Cblltrni 190 per cent to lOLO per cent (dried substance)

egraveHARACtERs Appeimincegrave whigravete or aImost white crystalline powder Solubility very soluble in water freely soluble in aIcohol

IDENTIFlCATION Pitst identificanon C D 8econd idefltijication A B D A Meltittg poitlt (2214) 168 middotC to 172 C 3 DissOlve 511mg in alcohol R and diIute to 1000 mL with

tl1egrave sagravemegrave sogravelVent Examined between 230 nm md 350 nm theacute SOlutioiigrave shows 3 ahsorption maxima (2225) at 253 llfIigrave 258 Iigravem and 264 nm The ratio of the absorbance iIfegravetsured at the maximum at 258 nm lo that measured at tJre tilaximuigraven at 253 nm is 11 to 13 The ratio of the absogravettrance measured at the mamnum at 258 nm to that nleasUred at the maximum at 264 nm is 12 to lA

C Ii1fntted abSorption spectrophotometry (2224) PfepariJtiofl discs

CompariSon diphenhydramine hydrochloride CRSbull D lt giVes the reactions of chlorides (231)

TESTS

Sogravelntion S DiSsolve 10 g in carbon dioxidejree water R and digraveIute to 20 mL with the same sovent

Agraveppearllnceof solugravetion Solution S and a tivefold diIution oC solution Sate clear (221) Solution S is not more intensely totoured than reference solution BY6 (222 Method II) Acldity 01 alkaJinity To 10 mL of solution S add 015 mL of metligraveyl red solution R and 025 mL oC 001 M hydrochloric acido Tbe solution is pink Not more than 05 mL of 001 M sodium hy1iraxide is required to change the colour of the indigravecator to yegravellow

Rilitted snhstances Liquid chromatography (2229)

Test solufion Dissolve 70 mg of the substance to be examined in the mobile phase and digravelute to 200 mL with the mobile

2073

EUROPEAJIl PfARMACegravefPOEIA 80

ASSAY Dissolve 0150 g in 50 mL of ethanol (96 per ermi) R md add 50 mL of001 M hydrocll1aric acido Carty aut a potentiomeu-ilt titration (2220) using 01 M sodium hydmxide Read the voltiine added betwegraveetl the 2 points of inflexion

1 mL df 01 M stldium hydrorlde is egravequiVagraveleacutetit ta 2017 mg df ~J1~ClNO

STOMGE ProtegraveCted frtlwllght

lMPURlItEgraveS SJietified impitritfegraves A Other detectable imptlfities (the f6llowng substances would ifpresent at a sugravefident leveacutel be detected by one or other of the tests in the monograph They are limited by the generai acceptance criterion for otherunspecified impurities andor by tbe generaI monograph Substances for pharmaceutica use (2034) It is tberefogravere not necessary to identify tbese impurities for demotlstrlltion of cotnpliance See also 510 Qmttol ofigravettrfrurities in subswnces for phaliriaurttiti1use) B

~~raquoO rr middotI~V ~

A (-)-(lR)-I-l1ydioxy-[-phenylpropan2one

H9lI~

~~~ B (lS2S)-2-(tnethylamino)-1-phenylpropan-l-ru

(pseudoephedrine)

Oligravell080715 coftected 60

EPHEDRINE HYDROgraveCmORlDE RACEMIC

Ephedrini raceInici hydtochloridum

MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]

Df1lNtrION Racemit ephedtme hydrochloride contains not less than 990 pa- ceI1t and not mCte than the eqUiValent of 1010 per ceacutefit of (1RS2SR)-2-(megravetligraveyl~iigravelograve)-I-ptrettylptopagraven-l-ol hydfochlotide calcuJategraved with referenre to the dt1w sugravebstlmce

CHARACTERS

A white or almost white crystalline powder or colourless crystals fteely soluble in water soluble in ethanol (96 per cent)

1t melts at about 188degC

IDENTIFICATION

First identification B E

Secund identiftegraveatiigraveYn A C D E A Optical rotation (see Tests)

Generai Notices (1) appy to ali monographs atld other text$

Bplregraveugraverligrave1e hydrochloride racemic

S Exatnine by iigraveIfrated absotption spectrophotometry (2224c) lt01tlpann With tlic spectrum QbtaIgravemd with raclfmic ep7tedriflie hjilriYdflatide CRS Examine the stdstlmtegraveS pt~ agraves disCs

C EXltinine the digravetOlnlIt6gtafusobtained in the test for fegravelatei SliJjltl(fiieacutes TIiepnficipal spot in the chromatogram obtiillled Wfth teSt SiJliidograveh (b) is silIgraveliIar in position colouriltilisttegrave fu mellnhtl-pal spot in the chromatogram ograveBtlUnedWim ~t~s()lt1tion (a)

D ToO1 fiildfs6hltttmS(Sleacute TeacuteSts) add 1mL ol wateT R otttlt (if ~ltiffitt~$Vltawn R and l mL ofstrong Wagraveiilm hfoirlfXidt SilltamptI R A Violet colour is produced ~dd 2 i1iL dt tth~ Rmtl shllke The ether layer is purple and the aqueotrs ltyir iii bIne

E To 5 mL of srumiograven S add 5 mL ofwater R The solution gives reaction (a) of chlorides (231)

TESTS

Sugraveltttion S Diampsol~ SigraveYO g in distilled Nater R and dilute to 500 mL With the same sogravelveiit

AppegravelltlilDle oflOltigravetiU11So1ution S is dear (221) and colograveurless (222 NfethUd lT)

Acl1Igravelty or agravelkalWy To lO tnL of solution S add 01 mL ol fttethyl tlrd softtilJn Rmd 01 mL of001 M sodium hydroxide clie solugravetion ili yegraveIlow Add 02 mL of 001 M hydrochloric arid the Sograveltttion is red

Qptical rotatlon (221) + 02middot to - 02deg determined on solution S

Related substlmcts Exagravemine by thin-Iayer chromatography (2227) using silica gel G R as the coating substance

Test solatiotl (a) Dissolve 010 g of the substance to be exatnined in ttrethana R alld dilute to lO mL witb the same solvent

Test sulutiofl (b) Dilute l tnL of test solution (a) to lO mL with methaflol R Riference solutiofl (Ii) Diss(jl~ 20 ng of meemie ephedrine hydrochdritlegrave CRS in methaflOl R and dilute lo lO mL with the same sohtent

Refugraveence soution (b) Dilute l mL oftest solution (a) to 200 tnL with methlilf() R Apply slparately lO the plate lO L of each solution Develop oVer a path of 15 egraveIn using a mixtligravere of 5 volumes of choro(orm R 15 vogravelutnes df concentrated ammonia R and 80 volumes of 2-prllJ1llnol R Afiow the pIate to dry in air Spray with nitlhydrin soltitigraveifn R and heat at 110degC for 5 min Any spOl in the chttItnatogr-am obtained with test solution (a) apart from the principal spot is not more intense than the spot in the cbrotnatogtam obtagraveined witb reference solution (b) (05 per ceacutent) Disregard any spot oflighter colour than tbe backgt6itnd

Sulfates (2413) 15 mL egravelf Sogravelution S complies with the limit test for sulfates (l00 pptn)

LOS5 on dryil1g (2232) Not more than 05 per cent d~etmined art 1000 gby dr)iing in an oven at 105 DC

Sulfated adigrave (2414) No more than 01 per cent determined on 10 g

ASSAY

Dissolve 0170 g in 30 mL of ethanol (96 per cent) R Add 50 mL of001 M hydroehloric acido Carry out a potentiometrigravec titration (2220) using 01 M sodium hydroxide Read the volume added hetween tbe two points of inflexigraveon

l mL of 01 M sodium hydroxide corresponds to 2017 mg of COHJ6C1NO

STORAGE Stare protected from ligltt

2143

Ephedrine hytlrocltloride

Slllfated am (2414) Not more than 01 per cent determiIied on l0 g

ASSAY Dissolve 0200 g in 5 mL of alcohol R and add 200 mL of01 M hydrochloric acido Uslng 005 mL of metityl red solution R as indicator titrate with 01 M sodium hydroxide ugravetitil a yellow co1our i5 obtained l tflL of 01 M hyagraverfJchlo7iegrave acrd is et(tiigraveVllIgraveeiigravet to 1652 mg of CwHsNO

STORAGE Stote protected from light

01zaOSIM87 orrected 60

EPHEDRINE HYDROCHLORIDE

Ephedrini hydrochloridum

10M ~AU I~~~ HCf

CoH16QNO MiDi [50-98-6]

DEFlNITION

(IR2S)-2-(Methylarnino )-I-phenylpropan-l-01 hydrochloride Content 990 per cent to 1010 per cent (dried substance)

CHARACTERS Appeagraverance white or almost white crystalline powder or colourless crystals Solubility freely soluble in water soluble in ethanol (96 per cent) mp about219 middotC

IDBNTIFICATION First identificatigraveon B E Second identification A C D E A Specific optical rotatioIgravel (see Tests) B Infrared absorption spectrophotometry (2224)

Comparison ephedrine hydrochlaride CRS e Thin-layer chromatography (2227)

Test solution Dissolve 20 mg of the substance to be examined in methanol R and dilute to lO mL with the same solvent Reference solution Dissolve lO mg of ephedtine hydrochloride CRS in methanol R and dilute to 5 mL with the same solvent Pate TLC silica gel plate R Mobile phase methylene ehloride R coilceltttated ammonia R 2-propanol R (51580 VIVIV) Application lO L Development over 23 of the plate Drying in air Detection spray witb ninhydrin solution R heat at 110 C for 5 min Resuts the prindpal spot in the chromatogram obtained with the test solution is similar in position colour and size to the principal spot in the chromatogram obtained with the reference solution

D To 01 mL oi solution S (selt Testo) add l mL of water R 02 mL of copper sufate solution R ami l mL of sttoiigraveg sodium hydroxide soutiOll R A vio1et colour igraves ptod1ced

EUROPEAN PHARMACOPOEIA 80 L~

Add 2 mL of methylene ehloride R and shake The lower (orgmic) laya- is dark grey and the upper (aqueous) layer is b1ugravee

E To 5mL oi sogravelution S (see Tests) add 5 mL of water R The solution gives reaction (a) of chlorides (231)

TESTS Slt41ition S DIssolve 500 g in distilled water R and dilute to SOO mL wlth ilie sarne solvent

AppeacuteagraveilliflCe of $OlutioD Solution S is dear (221) and -ologravetlrlligravess (222 Method II)

Addlty Or agravelkiugraveinity To lO mL of solution Sadd 01 mL of methyl red falufion R and 02 mL of 001 M sodium hydroxide The solutiograven is yellow Add 04 mL of 001 M hydrochlorie licid The solution is red

Sped1igravet optical rotation (227) - 335 to - 355 (dried substanee) Dilute 125 mL of solution S to 250 mL with water R

Related sUlIstlll1ces Liquid chromatography (2229) TegraveSt sulritittn Dissolve 75 mg of tbe substance to be examined in tlre mobile phase and dilute to lO mL with tbe mobile phase R1fermce sograveIution (a) Dilute 20 mL of the test solution to 1 000 mL witb the mobile phase Dilute l0 mL of this solution to 100 mL With the mobile phase Riference solution (b) Dissolve 5 mg of the substance to be etltmi1fed and 5 mg oipseudoephedrine hydrochloride CRS in the mobile phase and dilute to 50 mL with the mobile phase ColUiflll - size l 015 m 0 46 rom - statioftttry phase spherigraveccedilal phenylsilyl silica gel for

chromatagraphy R (3 pm) Mobile phase mix 6 volumes of methanol R and 94 volumcs of a 116 glL solution of ammonium acetate R adjusted to pH 40 with glacial acetic acid R Flow rate 10 mLmin Deteeacutetigraveon speCtlophotometer at 257 nm Injection 20 flL Run time 25 times the retention time of ephedrine Relative retentian witb reference to ephedrine (retention time = about 8 min) impurity B about 11 impurity A =about lA System sUitabigravelity reference solution (b) - resolution rninimum 20 between the peaks due to

ephedrine and impurity B

Iimigravets - correetion factor for tbe calculation of content multiply

tbe peak area oi impurity A by OA

- impurity A not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (02 per cent)

- unspecifted impurities (or eaccedilh impurity llot more than 05 times the area ofthe prindpal peakin tbe chromatogram ogravebtained With reference solution (a) (01 per cent)

- sum cfimpurities other than A not more than 25 times the area of tbe principal peak in the chromatogram obtained with reference solution (a) (05 per cent) disregard limit 025 times the area of the prindpal peak in the chromatogram obtained witb reference solution (a) (005 per cent)

Sulfates (2413) maximum 100 ppm determined on solution S

LOSi OD drying (2232) maximum 05 per cento determined on 1000 g by drying in an oven at 105 0e Sulfagraveted laquo$h (2414) maximum 01 per cent determined on 10 g

See the information secfion on generaI monographs (caver pages) 2142

Prochlogravetpemzine maleate

H1agraveVf mriils(24lt8) Dis-Solegrave LO gin wlitet R md digravelUt~ tb 2SOgrave mlvtrili theSiMeacute igt01Veacuteftt c~ oattheptelitfr1tIgraveUn lO mL d tJiiepretifttigravelte oomplieacutes wftligrave test E (5 pj5m) Pf1r1lte tl1e refenmce 5Oh1tion iising 5 mL of lettd stlntdtttd slTlatkrn (J ppm Pb) R LOgrave5S oil dtyittg (2132) ~cit mogravere ilian 05 per cent detennined on 100 gby drying in m ovm at 105 C

Sulfated asli (2414) Mot mote than 01 per cento determined 011 10 g

ASSAY

DisSugravel~ OAOO gin 50 mL ofdigravellite hydrachlaric aeid R CilrI1 dugravet ilie d~ation af ptimatY arQttJatic agraveI1lligravelo nittogen (258)

l mL of 01 M sotIiugravein nitrite is egravequinlent to 2728 mg of CuPItIClNj 0 2bull

stORAGE

Stote ptotected from light

0720100244

PROCBLORPERAZINE MALEATE

Ptochlorperazini maleas

~N~Nl fccedilCOif1 -_SUgrave

- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION

2-Chloro-lO- [3-( 4-methylPiPerazin-l-yl)proprll-l0Hshyphenothiazine bis[liydrogen (Z)-butenedioate

Cantent 98Ograve per cegravent to 1010 per ceftt (dried substai1d)

CIlAltACTERS APteatagravencegrave Whlte or pagravele-yegravellow crystalllne powder

Srtlubility Vegravety slightly soluble in warer and in ethanol (96 per eacuteeht)

IDENTIFICATION

First identification B C D

Second identifitation A C D

A Ultravigraveoet and isible absorption spectrophotometry (2225) Carry aut the identificatian test protected from light and metiSure the absarbances immediatel)

Test salution (a) Dissolve 50 mg in 01 M hydrochlotic atid and dilute tr1 5000 mL With tbe same acid

Test soltUib71 (b) DiUlteacute 100 mL of test solutioil (a) to 1000 mL Witb 01 M hydrochlogravetic acid

Spectml tagrave1Ige 280-350 nm for test solution (a) 230-280 nm for test solution (b)

Attsograverption maximum at 305 nm for teSt solution (a) agravet 255 nm for test solution (b)

Speeific absorbance at the absorption maximum al 255 nm 525 to 575 for test solution (b)

EacuteugravelOPEAN PHARMACOPOEIA 80

B ri1if1frldlllj~fI()iigrave petlttlphotdmetry (2224)

CimJ7dTifonprt1t~lte maleate CRS c IdtllIgraveiniatiOn ~tforplren(jthiazines by thin-Iayer

clfrl1ffillftfgfip1fY (Z33)mth tbe folloWing moditications

Test ialugraveffim 5iSllfflvegrave 20 mg of tbe substance to be ~ed ID a mifttitegrave OfegraveqUID volumes of methanal R ald methyleiie chiOtille R and md dilute to 20 mL With tbe samemiXtUre or solVlligravets

Refetl1nce soliJti1t Jgtissolve 20 mg ofprochlorperazine maUgravefategrave CRS in a ftliXfilte of equa volumes of methanol R and midhlWIe ehorme R md and dilute to 20 mL With the sigravefIDigrave igravellfrtaie ograve ampGMlits

AJl1iligravetittiiifl4 a ntnttttate02gWith il tniXtUreacute of l mL of strong sodium

hydroeitlt soZfiftfm Rmd 3 mL of water R Shake witb 3 qJtantmegraveS eigraveegraveh or 5mI ofether R To 01 mL of the aqueacuteOugraveli 1agravejgt1l add il solution of lO mg of resoreinol R in 3 mL or stIlfittic acid R Reolaquo in a water-bath for 15 min No oolout devegravelops To the remainder of the aqueous Iayer agravedd 2 mL af romilll soligravetlOn R Reat in a water-bath for IS min and theh heat to bograveiling Coo To 01 mL ofthe SogravelutiOn add a solutidn ofIO mg ofresorcinol R in 3 mL of sulfuric acid R Reat in a wilter-batb for lS min A blue co1our devclbps

TESTS

pB (223) 0 tigt 40 fur a freshly prepared saturated solution in carbon diOXide-free watltr R

Rdatiu ~tanCis Thinlayer chromatography (2227) Catry aut the teSt j1rtltected jrom light

Sogravelvetit miomre diethylllffline R methanol R (595 vV)

Test salugravetitJn Dissolte 02 g of the substance to be examined in the solvent miXtute and dilute to lO mL With tbe solvent tiigraveXture Prepare fue solution immediately before use

Riiference salUfion lJilute l mL oftbe test solution to 200 mL with the solvmt miXttlre

Plate Tre silica gel Gl25 pate R

Mobile pha5e acetone R dieth)lamine R C)lclohexane R (101080 VIVV)

ApplicatiMI lO fil Developmmt oter 23 of the plate

Dyitlg ID ait

Detecti01l enttri1re in ulttavigraveblet light at 254 nm

Lifflit any spot apart from the principa spot is not more intense tban fue spogravet in the chtomatogram obtained Witb the reference solution (05 per cent) disregard any spots remairung at theacute points of appHcation

Loss on drying (2232) m3XIgrave1llum 10 per cent determined on 1000 g by drying in m oven at IOS C

Sulfated ash (2414) mmmum 01 per cent determined on l0 g

ASSAY

Dissolve 0200 g ofiliegrave powdeted substance to be examined in 50 mL of anhydrous acetie acid R warming on a water-bath Allow to COdI te room temperature Titrate Witb 01 M perchlOtic acid degravetermitling tbc eftd-point potentiometrically (2220)

1 mL of 01 M perchlaric add is equivalent to 3031 mg of CHPNsdegaSmiddot

STORAGB


See the information section on generai monographs (cover pages) 3104


CRARACTERS

A wltite or 1fty sllgbtlt jWiow egravel]stiillinepowder Itygrdsecteacutedph vety soIugravebIE iIgravell1~ freeJyblubIe in ll1brhtll slightIy li61uble in atettllle

IDEllTIFICATIDN

First ideMiftccedilation C D

SecDnd identification A B D E

A Melting point (2214) 166 ~C to 170degC

B Dissolve 100 mg in 01 M $odium hydrogravexidli md dilute to 1000 mL with the slimegrave solvent Dilute 100 mI or the solution to 1000 mL With 01 M sl1dium Itjdro~de Etatllineacuted belWeacuteeacuten 220 Dm md 350 Iim (222S) tligraveeacute solutieacute1n shows alI ab~tl1fimiddotofl ttlaigraveititliliigrave at 173 4m fieacute spetific absorbmce al the igrave1latilfiugravem js 580 (o 610

C Efaltlirte by Igravenfrnred all-sotptiograven speitro1l1otogravem~ (2224) comparIgraveIgravelg With tlie 5pectrIlm ogravebtilitteacutetl Wifu protainalnide hyagraverochlDfide CRS

I) Dilute l mI of s61ution S to 5 migrave With water R Tlle solution gives teaction (a) of ch10tides (231)

E Dilute 1 mL ofSolution S (see Tests) to 2 tnL with water R l mL ofthis solution gives fue teagravedIgraveOgravel1 of pnmary atOtiIllltic amines (231)

TESTS

Sogravelution S Dissolve 25 g in carbon dioxide-free water Rami dilute to 25 tnL with the sante solvent

AppearlUlegravee of501ution SolUtion S is dear (221) and fiogravet mOre iuteilsely cograveloured than referenee solutitm B6 (222 Metltodm

pH (223) The pH of1I0lutiograven S is 56 to 63

Itelated sugraveb$tagravellces ExamIgravefle by thin4aYegraver drrogravemat(Jgraphy (2227) using silica gegravel GF15lt R as tI1e cOating substigravence

Test solution Dissolve 010 g or the substance to be exartrlned in alcohol R and dilute to 10tnL with tI1e sante solveacutent

Reference solution Dilute l mL of tI1e test solutian to 200 mL with alcohol R

Apply to the piate 5 J1L of each solution Develop over a path of 12 cm using a mixture of 15 volumes ofgiadal aCegravetic acid R 30 volumes ofwater R and 60 vo)umes of butanol R Piace the piate in a stream of coM ai until the pbrte appears dry Examiire in ultraViolet light at 254 Iigravettl Any spot ili the chromatogram obtained with tbe teSt solution tpatt ftdln tI1e prindpaJ spOt is not more intense than the spbt in tltegrave chmmatogtam obtained witl1 the refereacutence solution (05 per Ceacutent)

Heavy metals (248) 10 g eomplies with test C for heavy metaJs (20 ppm) Prepare the referenee solution using 2 mL oC lead standard solution (lO ppm Pb) R

Los5 on drying (2232) Not more tI1an 05 per cento determined on LOOO g by drying in an oven at 105 DC

Sulfatcd ash (2414) Not more than 01 per cent detetrnined on 10 g

ASSAY

Dissolte 02500 g in 50 mL of dilite hydrochlotic aOd R Carty out the determiuation of primary aromatic amino-IIittogravegeb (258)

l mL of 01 M sodium nitrite is eqUivaleJrt to 2718 mg of ClHuClNp

STORAGE

Store in an airtigbt container protected fram light

Generai Notices (1) apply to ali monographs and other tetts

Proeme hydrocltloride

0120080050 corrected 70

nOCAINE HYDROCHLORIDE

Procaini hydrochloridum

O (aiadON~CH3 bull HCI

HtN

C1lziClfP M2728 [51-()5l8]

JJimmftON P~egrave ltydriJdtlotide contains not less than 990 per cimt milITO mote than the equivalent of 1010 per centofi~(~amiilo )ethyl4-atllinobenzoate hydrochloride alcuft$d Mili refetence to the dried substance

CRAampAegravelERs A wllite dr agravelmost wrute crystalline powder or colourless ciywrals veacuteigravey soluble in water soluble in ethanol (96 per cent)

IDENTiFiCATION Fitst identijigravecation A B E Second identification A C D E F A Melting point (2214) 154 DC to 158 middotC

B Etamihe by infrared absorption spectrophotometry (22U) comparing with the spectrum obtaigravened with ]ffocltigravene hydrochloride CRS

egrave 10 aboigravelt 5 mg add 05 mL offuming nitric acid R Evaporate to ilryneacutesS on a water-bath allow to co61 and dissolve the rmdtie in 5mL of acetone R Add l tnL of 01 M alcoholic poliMtium hydroxide Only a brownish-red colout develops

D To 02tnL of solUtion S (see Tests) add 2 mL of water R and 05 mL of dilute sulfuric acid R and shake Add l mL or a l giL sogravelUtion ofpotassium permanganate R The colour ilgt ittJrilediately discharged

E It gives reaction (a) of chiorides (231)

F DiluteltnL of solution S to 100 mL with water R 2 mL of this solution gives the reaction of primary aromatic amigravenes (231)

fFSrs SoltltiOigrave1 S Dissolve 25 g in carbon dioxide1ree water R and dllme to SO fiL with the same solvent

AippeacuteatlUigravete of sollltion S61ution S is dear (221) and cdloutless (222 Method m IH (223) Dilute 4 mL of solution S to lO mL with carbon diolidefree water R The pH of the solutigraveon is 50 to 65

Related sllbstagravellces Examine by thin-Iayer chromatography (2227) using silica gel GF154 R as the coating substance Test solution Dissolve 10 g ofthe substance to be examined in water R and dilute to lO tnL with the sarne solvent Reference solution Dissolve 50 mg of4-aminobenzoic acid R in water R and dilute to 100 mL with the sarne solvent DUute l mL oftl1e solution to lO mL with water R Apply Segraveparately to tI1e piate 5 fiL of each Solulion Develop ClVer a path of lO cm using a mixture of 4 volumes ofgladal acetit add R 16 volumes of hexane R and 80 volumes of dibutyl ether R Dry the plate at 100degC to 105 middotC for lO migraven and examine in ultraviolet 11gbt at 254 nm Any spot in the mromatogram obtained with the test solution apart from the principal spot is not more intense than the amppot in the chromatogram obtained with the reference solution (005 per cent) The principaJ spot in the chromatogram obtained with the test solution remains OD the point of application

3103

Cognome e Nome

SCHEDA DI PREPARAZIONE Fonte di legittimazione Farmacopea

O

Prescrizione medica del Ndeg

M

Forma farmaceutica Riferimento alla procedura tecnologica Avvertenze e precauzioni

Componenti CodInterno Lotto Quantitagrave unitarie

Compilare se preparazione allestita unrsquounica volta e che dunque non richiede foglio di allestimento Barrare se impiegato per motivi tecnici Controlli previsti Contenitore Periodo di validitagrave Disciplina di vendita (senza ricetta RR RNR RRM) Metodo di preparazione

SIgrave NO OBBLIGO DI REGISTRAZIONE IN USCITA

Cognome e Nome

SCHEDA RICETTA Tipologia RR RNR RNR (tab 3) RRM SSN La ricetta risulta spedibile sigrave no percheacute Validitagrave temporale ed eventuale ripetibilitagrave della ricetta in oggetto Formalismi obbligatori per il medico per la ricetta in oggetto Formalismi obbligatori per il farmacista per la ricetta in oggetto Presenza di veleni sostanze molto tossiche sost stupefacenti e psicotrope registrazione registro EU coloranti o corrosivi sostanze vietate per doping Modalitagrave e tempo di conservazione della ricetta Data limite di utilizzo della preparazione Uso UI UE Forma farmaceutica Controllo di qualitagrave obbligatori per le NBP Attivitagrave terapeutica della preparazione

ndeghelliphelliphelliphelliphelliphelliphelliplihelliphelliphelliphelliphelliphelliphelliphellipDotthelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Avvertenzehelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Precauzionihelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Posologiahelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip helliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Data limite di utilizzohelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip Sighelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphelliphellip

Segue TABELLA N 8

S o s t a n z a Viedi somministrazione

Dosi abituali Dosi massime

Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi

Acido mefenamico per os ^ ^ 0500 15

Acido nalidixico per os 050 2 1 4

Acido nicotinico per osscev

005-020005-010005-010

030030020

030020020

111

Acido ossolinico per os ^ ^ 075 15

Acido pipemidico triidrato per os ^ ^ 0471 0942

Acido salicilico top pom (crema ung gel ecc) loz cerotto shampoo sapone ecc 1 24 25 40 60

Acido tiaprofenico per osrett

^ ^ 0603

0606

Acido tolfenamico per os ^ ^ 02 06

Acido tranexamico per osev lenta

^^

^^

0025kg0015kg

01kg0045kg

Acido tricloroacetico top ^ ^ 50

Acido undecilenico top ung 5 (in ass con Zn undecilenato) polv 2-5 (idem) aerosol 2 (idem)

Acido ursodesossicolico per os ^ ^ ^ 0012kg

Acido valproico per os ^ ^ 0030kg 0060kg

Acitretina per os ^ ^ 0025 0075

Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03

Adenosina ev rapida ^ ^ 0012 0021

Adrenalina cloridrato im o sc 00002-0001 0001 0001 0003

Adrenalina tartrato acido im o sc 00002-0001 0001 0001 0003

Ajmalina per os 005-010 015-060 030 060

Ajmalina monoetanolato per osim o ev

005-010005-010

015-030020

^^

040020

Alanina fleboclisi In combinazione con altri amminoacidi nelle soluzioni perfusionaliper la nutrizione parenterale

Albendazolo per os ^ ^ 04 04

Alcool isopropilico top sol al 70 ^ ^ ^

Alcuronio cloruro ev ^ ^ 0000250kg 0000300kg

Alfacalcidolo per os ^ ^ ^ 0000001

Alfentanile cloridrato ev 01 02 ^ ^

Alfuzosina cloridrato per os ^ ^ 00025 0010

Allobarbital per os 010-020 020 020 030

Allopurinolo per os 010-020 020-060 030 080

Alluminio cloruro esaidrato top sol al 20 ^ ^ ^

Alluminio ossido idrato per os 050-1 2 1 4

Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali

Dott xxxxx xxxxxxxxx

Via xxxxxxx xxxxxxx xx

Torino

Tel xxxxxxxxxxxxxx

Sigra xxxxxx xxxxxxx

R Acido salicilico 2 g

Zinco ossido

Amido polvere (frumento) ana 25 g

Vaselina qb 100 g

Zinco ossido e acido salicilico pasta cutanea (FU XII)

Spedire 30 g

2-3 applicazioni al digrave

26062015

_______________________________________________________________________

UTILIZZARE IL FOGLIO PROTOCOLLO A QUADRETTI UNICAMENTE PER I CALCOLI

UNJ)E8ilIAogQJSfJjBilJplIORINO

1~rSfJITOPffL~TADmI AtegraveN~LIlA~~SlONE DI FARMACISTA

PAtMASESsIONEOU

PWDVA tAfrtk PIViagrave tifi tittmOStirtriltltb del farmaco

cogravegtrOrt1e e hGme bull- - bullbullbullbullbullbullbullbullbullbullbullbullbullbullbull - bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull

1l(J~ttQto(QtrSigravegteamp~~~ittietttQmiddotdldtJfffam

Per ogni farmocO vIene fornilo il profilO sperimenfale (sequenza delle analisi effettuate] ed UtrCl irigraveoieCIZione di pdssibHi for1YlOci candidati corredati dalle rispettive monografie provenienti dolio Farmacopea Europea (Ph Eur 8)

AI candidato viene riChiesto di

bull individuerei fortntJegraveO che megfio cOOi~pondeal profilo fornito mOtivare lJre~emeacutenteacute lO propria scelto proporregrave unulteriore provo sperimentale CI Conferma della scelta effettuata

~1N~ntba~I~Pfi1fO(~




~ CH3 Ha HCIcn CH3

H2N~ tfCI










~~ 2 0O OH - Na






~ t

23 rDENTlFrCATION

011200amp20301




ACETYL



ALKALOIDS


ALuMINlUM



AMMONIUM SALTS








BBNZOATBS



BISMUTH




119







CHLORIDES



CITRATES





IRON



LACTATES


LEAD










SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


~1N~ntba~I~Pfi1fO(~




~ CH3 Ha HCIcn CH3

H2N~ tfCI










~~ 2 0O OH - Na






~ t

23 rDENTlFrCATION

011200amp20301




ACETYL



ALKALOIDS


ALuMINlUM



AMMONIUM SALTS








BBNZOATBS



BISMUTH




119







CHLORIDES



CITRATES





IRON



LACTATES


LEAD










SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________






~~ 2 0O OH - Na






~ t

23 rDENTlFrCATION

011200amp20301




ACETYL



ALKALOIDS


ALuMINlUM



AMMONIUM SALTS








BBNZOATBS



BISMUTH




119







CHLORIDES



CITRATES





IRON



LACTATES


LEAD










SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________



~ t

23 rDENTlFrCATION

011200amp20301




ACETYL



ALKALOIDS


ALuMINlUM



AMMONIUM SALTS








BBNZOATBS



BISMUTH




119







CHLORIDES



CITRATES





IRON



LACTATES


LEAD










SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________








CHLORIDES



CITRATES





IRON



LACTATES


LEAD










SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________









SALICYLATES


SILlCATES




SIl~




SULFATEgraves





XANTHINES


ZINC


121

1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


1 GeneraI notices















TESTS AND ASSAYS


















Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


Sodium salicr1ate



ASSAY






o


o


ograve


0120080113 corrected 60

SODIUM SALICYLATE

Natrii salicylas

(XCO~ OH

C1HsNaO M 1601r [54-21-7]

















0120081677




















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________















ASSAY



STORAGE


IMPURITIES




(JOH C phenol



0120081765




CH4iND MT 604 [94749-08-3]

DEFINIrtON













0-16 100 O

16 36 100 ~ 30 O~ 70

36 - 45 30 70

45-50 30100 70 O




3199







OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________








OH


ifHOHHCI Iligravec~

Hac ~ MlI~ iO

011



oCIi~


VOI ~ clia


li NXCils

liQN 0 Cfi



o unknown structure


SAUCYlIC ACro

Acidum salicylicum

cr~ OH

M 138 1 C7H60 [69-72-7] r


CHARACTERS


3198




TssrS































R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________

















R f ~ nd~

R

gz0-- CHa







0420120819



oQ~O OeH

~ilA~ClN20Z M4891 [3810808]






TEStS














IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________











IMFURtrms

o~shyCH


~~ tr-OOW middot 0

HO HOmiddot 110

QII Oli O



HO R3

OH OH o






kli

Ogravef O


0)20080023 corrected 60



J CH tICl bull

O~N~

Cl7HllClNO M2918 [147-24-0]







TESTS





2073








H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________









H9lI~


(pseudoephedrine)




MOli

~ ~~ ~ MCIV tl~

ClOH16ClNO M2017 [134-71-4]


CHARACTERS



IDENTIFICATION









TESTS












ASSAY




2143








10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________









10M ~AU I~~~ HCf


DEFlNITION




























ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________





ASSAY



stORAGE


0720100244




- _ _ llvtc~ t f

OtAJ2 a

CtgR1C1N10s M60o [84-02-6J

DEFINITION





IDENTIFICATION

















TESTS









Dyitlg ID ait





ASSAY



STORAGB




CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________



CRARACTERS


IDEllTIFICATIDN








TESTS











ASSAY



STORAGE




0120080050 corrected 70




HtN

C1lziClfP M2728 [51-()5l8]












3103

Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


Cognome e Nome


O


M





Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


Cognome e Nome




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________




Segue TABELLA N 8



Per ogni dosegrammi

Nelle 24 oregrammi

Per ogni dosegrammi

Nelle 24 oregrammi




005-020005-010005-010

030030020

030020020

111





^ ^ 0603

0606



^^

^^

0025kg0015kg

01kg0045kg






Aconitina per os 00001 00002 00002 00005

Adenina per os 0015-003 015 003-006 03




Ajmalina per os 005-010 015-060 030 060


005-010005-010

015-030020

^^

040020












Tabelle

Indice

Preparazioni

Omeopatic

he

Preparazioni

Farm

ace

utiche

Specifiche

Materie

Prime

Form

eFarm

ace

utiche

Monografie

Generali

Argomenti

Generali

Reattivi

Materiali

Contenito

riMetodi

diAnalisi

Presc

rizioni

Generali



Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________




Torino

Tel xxxxxxxxxxxxxx



Zinco ossido


Vaselina qb 100 g


Spedire 30 g


26062015

_______________________________________________________________________


UNIVERSITÀ DEGLI STUDI DI TORINO · 2015-10-06 · UNIVERSITÀ DEGLI STUDI DI TORINO ESAME DI...

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Transcript of UNIVERSITÀ DEGLI STUDI DI TORINO · 2015-10-06 · UNIVERSITÀ DEGLI STUDI DI TORINO ESAME DI...