Quantiti/Quantily:

25.000

Prodotto/Product: RANITIDINA CLORIDRATO RANITIDINE HYDROCHLORIDE

Sinonient/Synonyms:

Formula:

CI3H22N403S-FICI

Peso molecolan/Molecular weight:

350,9

Identificazione/Identification:

IR

Peso molecolare/Molecular

350,9

Quiintiti/Quantity:

25 OGO

Identillcazione/Identification:

IR

Prodotto/Produrt: RANITIDINA CLORIDRATO RANITIDINE HYDROCHLORIDE

Sinonimi/Synonyms:

Formula:

CI3H22N403S HCI

Deserizione/Descrintion Idenglkazione Idenitficamon

ANALYTICAL TESTS Risultati/Rulls Spreilielie/Sperificalion (1.010.«, (4.10

k ni R14 f, Fut Deserizione/Oeserintion lispdrezza Glatpurity G

Risultati/Results Specifiche/Specifsealion NOT

0.2 %

Cunlinwee Caspha

C'entffirrne fintipkes

Confrwme Cumphes

<-• 3500 ppre

98.5 - 101,5 %

0,02 %

0.01 %

100.4 %

c= 0.05 96

NOT

0.05 %

NDT

Nor

NOT

lainfrezza K Imprerili. H

larprorerza 1 Mpurriv

kipa= Plsopuruyi

lfflpitrer, ,.on speclficalelllnspeafied IrspstrUks

Somma dir Imparme diverse AiSlum ofimpuntier dilerenl from A 0.12%

&dvome • 011,114: Acetata JI a& Resnlual Flhyl OCCiOk 500 ppm

Solvenie rt sidera, Eran010 Re51,1ual advent Erhanol 3500 ppm

Solecnoc rnkhrt bropmno,Residita1 Jaken!: Chlorolorm 50 ppm

I•mpichi er manolenwhe Gogasaleprocpnywnei

A NreffiOdella sobnem, SAppemenct, oholialon

<kilo sulrelone tpl i 013,06m:ion. S

Sestane rorrelafe (HPICpRelcied ntb lallets (Hrte)

Alnalll pernati/Harry metali

Perdih, all'esaccomentoffireltoss un glry0,14 0$0.0

Cenerl sol firichaulphored Arh.

Molo,Assay

Impnre=0 Algnpioity

Improvizm Whopoorlty

krp:rens Olmpurlty C

Impurezzo Diregmerle •

Imptue:ra KlmpitHO. E

Impwena FinginoH0, F

o C.) PalY3 1 / 4 Page 2 / 4

ACOFARMA DISTRIBUCION S .A. QUALITY CONTROL LABORATORY

CERTIFICATE 6F ANALYSIS

Lotto materi* prima/Numero analisi - Raw material Bateb/Analysn number: 160222

ACOFARMA DISTRIBUCION S .A. QUALITY CONTROL LABORATORY

CERTIFICATE OF ANALYSIS

Lado materia prima/Numere analisi - Raw material Batelt/Analysis number: 160222

Parametri controllab dal produttore/Parameter controlled by the manufacturer

Prodano fabbricato da Acofarma Distribution S.A. e distribuito da Famalabor SRL Prioduct manufactured by Acofarma Distribution S.A. and distfibuted by Farmalabor SRL

it Parametri controllab dal produttom/Parameter controlled by the manufacturer

Pradotto fabbdcato da kotama Distribution S.A. e distrilxiito da Famalabor SRL Product manufactured by Acofarma Distribution S.A. and distrIbuted by Farmalabor SRL

ProdotIo/Product: RANITIDINA CLORIDRATO RANITIDINE HYDROCHLORIDE

QuandtarQualliRY

25.000

Sinonimi/Synonyms:

Formula:

C131422N4036 HCI

Po molecolare/Molecular weight:

350,9

Identificazionendentificalion:

IR

Questa certifitato di analisi si riferisce al seguenti fottf di prodati° Pnita. This certfficate of analysls refers to the following finished prodori batches.

DocNtifa ihte Product higine Git SalUnil Jatch g 160222-J-1 92.957 21/03/2016 1370082 RANITIDINA CLOMDRATO 100

92.958 21/03/2016 1370083 RANITIDINA CLORIDRATO 10 g 160222-F-1

92.959 21/03/2016 1200219 RANITIDINA CLORIDRATO 250 g 160222-N-1

92.960 21/03/2016 1200218 RANITIDINA CLORIDRATO 50 g 160222-1-1

92.961 21/03/2016 1175006 RANITIDINA CLORIDRATO 100 g 160222-1-2

92.962 21/03/2016 1175004 RANITIDINA CLORIDRATO 25 g 160222-0-1

F!') ACOFARIVIA DISTRIBUCION S.A.

QUALITY CON140L LABORATORY

CERTIFICATEOF ANALYSIS

Loti° materia prima/Numero analisi - Raw material Batch/Analysis «mbar:

Page 3 / 4

rti Page 4 / 4

ACOFARMA DISTRIBUCION S.A. QUALITY CONIRQL LABORATORY

CEFCTIFICATE OF ANALYSIS

160222 160222 Lotto materi' prima/Numero analisi - Raw material Bateh/Analysis number.

QuantitS/Quardi1YI

25.000

ProdotIo/Product: RANITIDINA CLORIDRATO RANITIDINE HYDROCHLOR1DE

Sinonimi/Synonyms:

Formula:

C131122N403S.HCI

Peso molecolare/Molecular weight:

350,9

Nen li ficazione/Iden ti fication:

IR

Caratteristiche organolettidie / Organoleptic charaelers:

Osservazioni/Observatiorts:

Conservazione/Slorage:

%hen ek... ro nocerrs« ~m daru.. p.č .iume evna,..... mane pse, ~le »tune a Ima< Whie pafi. nivo, ays.... rsodded Fre.Sy «as*. sfmntylit ••

uoldpit km~na ~Se

In conteniton ban 'anioni. Protegama dalla luce. / In tightly closed containers. Protect from light.

92.963 21/03/2016 1175004 WINMENNACLORIONATO

25

g

160222-G-2

92.964 21/03/2016 1175002 RANITIDINA CLORIDRATO

5

g

160222-E-I

92.965 21/03/2016 1175009 RANIT ioiNA CLORIDRATO .Kg

160222-P-I

Data ana liss/A na lyms data: 17/03/2016 lbsultalo/Result: CONFORME/ACCEPTED

Responsabile controllo qualita/Quality control manager:

O. Vilaplana

Produttone/ F00287

UtWIFAS.A. - Spaln '

Lotto del fomitore 12001510005

Manufacturer:

Supplier batch:

Persona qualificata/Qualified person: Carmen Bau Data di scadenza/Expiry data: 01/01/2018

Conformita / Conforme RFE5 - PhEur8.6 / Complias RFE5 - PhEur8.6

Complianee:

r Paramebi controllati dal produttore/Parameter controlIby the manufacturer

Prodottofabbricato da Acofarrna Distribution S.A. e dis buito da Famalabor SRL Product manufacture‘by Acofarma Distributiai S.A. and distributed by Farmalabor SRL

Parametn controllah dal produttore/Parameter controlled by the manufacturer

Prcdottofabtricato da Acofarma Distribution S.A. e disbibuito da Farnalabor SRL Praduct manufactured by Acofarma Distribution S.A. anddistributed by Farmalabor SRL