FARMALABOR Farmacisti Associati

Tre dIvisintli un'unitadl Jnnonli. PlflauttellirMita. 1-finte &trs tate-nest o aoNtte MW. Plodocc Guat(tY.

FARMALABOR ES; FARMALABOR › FAR MAL ABOR toob

CERTIFICATO DI ANALISI - CERTIFICATE OF ANALYSIS

Prodotto • ~duet 1537 MINOXIDIL - MINOXIDIL MINOXIDILUM

ConfOrmita - ComPltance EP Laro - Batch Number F1600249 Produttore - Manufacturer FARMALABOR Srl, Via Pouillo 2.1. - 76012 Canosa di Puglia (BT) - ITALIA Osla produzionentionubmining dalo : 20/10/2016 Data scadenza - EMIN date: 30/0912021 Dala ca analisilAnalysis dale: 2411012016

Produttore Materia Prim TRIFARMA - neha Raw material manufacturer: Via della Industrie 6, 20816 - Cada» Laghetto (MB) Lotto produttore mateda prima / Raw material manufacturer batch number: 416037

La ~rta plima a «ara ausodnau daril AWA Racete hen d., "na» a mu. (modam.' raPacaara aelbrily or ibis rame maradal la Mesnata tli AWA lAganala Matena ripacdt• prane rotilo.. lamucautl. Fani...bob ni Fanine)

Space eservato ega Farnacia

DATA RICEZIONE: Ni. INTERNO:

DATA VUTIUZZO: DATA FINE UTIUZZO:

COSTO: PREZZO AL PUBBLICO

NR DDT/FATTURA.

OUANTITN:

SIGLA RESP.LAB:

premene ken a Ralo labbdosto In OMP derottalne termacedica Farmalabc«, 'Nanesena. delbNenatt Haiena del ramam. Si enega cona det voNfIcam originale del predultore dela matena prima CONSERVAZIONE Non sonc posnste paracolad conaboo d sloccotEmb

< 0.05 Natega.. dala luce 0.15

CERTIFICANONE 11 prodnega della mesna puma OvNara che il amebe

BSE/TSE

0 pano ch opomnila:non« da BSEITSE • Teci mami. p(esso I Laboodon Conttollo Queen

Fatmalabot Test non cl mene

Tea bedi hes been manutractured to GMP by E,. phanntmetrUcal oS. st Farmalabcr. Nemete by AIFA (Agenda Kalana dal Fatenaco). Find attached Uln copy ol tli. Goltale ol analys•s o( trmmaterial mamka:luta.

STORAGE Spadal storege tonditions Ne not required. MUSI bo 13‘010ded POM

135ETTSE CER11FICBTE Tre manulacturet dadaree ffle produg 1s 135ETTSE OblaarrinatIOn (ret

Tests pedmmed by Farmalebods Ouafety Control lebbalortes Non1~in° ISSI

Imp.13:61ax 0.15% Unspecded Tobiasu: Max 0.10% Tel Ima.: lasx 02% Max 0.5%

< 0.0f < 0.05

Max01% <0.03 99 0% • 101.0% (bled

992 substance)

preSen1.8 dOCunlenb) l vedo senu Inna od • topla toaletne del cente° cO anale grmelo e apnele od mcNendo ki Farmalabor net realko batch rocon1

document Ot Vab! Nihata signalure and is a complant con or the analyse sigme In odene and vette in earmalabot In as bet.ChreCOrd 248•G - 26NG (Mm.)

255 (dec)

Mar O 5% (USP)

O

Max 20 pgn (1JEP) • 20 c 20 ppm c 20

< 125 um: ral lem than 100% 100 < 100 um: not less Ihan 90.0% 53. I 040/m1-001y1y4 0.4

Netkano, <- 503 ppm 61 Mam I sobot nol USed

Approvate da Ninom Quellfleeta l Approved by Qualltled PartOn Dr. Gabriella Chiepp•

rte di~nb un'unita tli int o it 11. PtOdUlte qball10. "mre Lit-twittiortni. wittiue odit PaWuce ovatity.

FARMALABOR Farmatisti Associati FARMALABOR FARMAL/9E10R C1 FARMALABOR 1:1

CERTIFICATO DI ANALISI - CERTIFICATE OF ANALYSIS

Predotto Product 1537 MINOXIDIL - MINOXIDIL - MINOXIDILUM

Conform Iti - Compliance EP Loti* • Batch Number F1600249 Produttore - Manufacturer FARMALABOR Srl, Via Pozzillo Z.I. - 76012 Canosa di Puglia (BT) - ITALIA Dala procludone/Manulac lining dale : 20/1012016 Data zaidem(' -EKONdata: 30/09:12021 Data do analtsYtriblysis dat.: 241102016

Produttore Mateda Prima TRIFARMA S.p.A. kana Raw material manufacturer: Via della Industrie 6, 20816 Ceriano Laghetto (MB) Lado produttore materia prima / Raw material manufacturer batch number 416037

La ~S parna • stala autearsaa dat AJPA (Apintla 10150. OS Farma.) ad 4.i.a Facroulabor rapackagIng «Mig al thil• rawinabblal k Iliarned by AWA <Anna' Itakan, aparata presto raleicina lamiaraulica Farmama... Fannacol

PESO PER UNITA' NOME CHIMICO th(ppetitan-1-11)prtroldlo-24-damina 3-osndo

NUMERO CAS 38304-91-5

FORMULA MCLECOUIPE C9HISN50

PESO MOLECOLARE 209 3g / mol

MINUSI MATERIN PRIMA 5PECIFICHE RISULTAII

CHEIAICAL NNVE 8-IPIPInidMI-1Oppiat00ne-2,4-chernine 3-oxIde

CAS NUMBER 38304,914

MOLEGUIAR FORMULA C96(15N50

MOLECULAR WEIGHT 2092 g / mol

RAW MATERIAL ANALISYS

SPECIFICAIIONS RESULTS

lAn 5 009 -Mac 5.30 tl 10

Nin 10.60 g -Mas 10.309 n/a

Mn 50_60g -Mex 5020 g Cofke= Min 10000 g • Mat 10020 g Na

kin 250 03 g - Mat 250.10 g tda

Mat 503.03 g -Mas 503.10 g Na

Mm 1030009-Mia I CO3.10 g n/a

UMT MIGHT CONTROL Inn 5.03 g -IAN 5.30g 05 Mol -10.00 -Max 10.30 g Na

len 50004 Mat 50.20 31 ENNIdes Mn 100.00 -Ms7 10020 g Ida Min 250.03 g • Mm 250.10 g Na

Mn 500.00 g - Max 501710 g rds

Mn 1600.000 -Mm 1000.10 g Na

PILEUR ASPETTO POPIere abWalfina [ionu o Cornornat

tmasl tlilno SOLUBILITN Pont sahibe en amis. C.ontorme

sobi.° in metanolu

IDENTIFICAZIONE IR C.110'11463 alio ~Trd Coulomb ' § SOSTANZE

Ima. E: Max O 2% • 0.05 CORRELATE THPLC)

Imp. B:Max 0.15%

< O 05 Ima. non spev.: Mar 0.10%

< 0.05

Tot. Imp.: Mac O 3% c 0.05 PERCITA Mav 0.5% 0.18

ALL'ESSICCANENTO § GENET° SOLFORICHE M,tOl% 0113

" IITC34.0 99.0% s 101.0% (soslanza essiccata)

ALTRI TEST PUNTO OO FUSIONE

24/PC -21384C (deo.)

255 ((1ec) PEADITA

Max 0.5% (USP)

0.1 ALLESSICCAMENTO METALLI PESASTII

Max 20 PPm CUSP)

< 20

' § METNAJ PESANII

< 20 ppm c 20

(Pb) GRANULOMETRIA

< 125 ms non mono di 100% 100 c 100 um non meno d 90.0% 98 I

DENS(TN AL

0.4 girri - O Eigki O 4 VERSAMENTO SOLVENTI RESIDU1

Melendo cs 500 ppm 60 Sobana Nesse I strm LollznO

ANAUN PROOOTTO FIMTO

SPECIFICRE

IDEN11FICA2IONE SIR Coulomb

Conlortris

COsbrlIONAMENTO Conforme Gadoma

PtLEUR APPEARANCE

SOLUBILITT

IR 10EN11FICAllON ' § RELATED SUBSTANCES KBM

' LOSS ON DRYING

§ &APNATE!) ASH ASSAY

OTHER TESTS MELTING POINT LOSS ON DRY1NG

IFJWYMETALS § HEAVT METALS (Pb)

PARTICLE SIZE

BULK DENSITT

RES01UALS SOLVENTS

FINISHED PRODUCT ANALYSIS TIR IDENTIFICATION

PAGKAG192 CONTFICt

BINte or Monet Nate. rampi es °Tnalam) povode( Saghtly soluble in water. Como», soluble in ~bana Gordana lo OIt standattl

Comti-s lnWn E:Max 02%

<11725

ALTRE MRMRATE DAL USP

OTHER

USP PRODUTTORE

MANUFACTURERS DECLARATION

ANNOTAZIONI

NOTES

CONFORMITN COMPTANCE

SPEOFIGAIIONS temper(

Comples

RESULTS Comptes

Cornblea

PARMALABOR Sel Read °NIN Via Pomba. zona Ind. • 76012 Tanen dI Popa ' ItalY tepal head olike Via Oberdan. SI • 15012 anosa di Posli (BO • Italy RapeseoladyeaffIte Cia Pakirna. 23 - 20030 Asnytt (tild (Det) dded - REA.A.UFB- TI 05536410721- Cap. Se C 360.000.001e

Phone •39 038319 tS 111 Far •39 0883664 824 Tak 800065 ?IM E-nzan int anualabomt Web www.lsetrubbor It

doomatuentmotnanami

Ifibt011k1•04 1.91.111erb»1

FARMALABOR Srt Readolike Vla Pozab). tena Ind. • MIZ Tanen di krpa IM • Italy letal head (T(ce trla (»enim. Sg • MII? Cases& tli Raglja (81) • Italy RepettentatInt oteka Via Palemo. 21 - 20090 A4t4§0 (Ml) • lIaly Caen et gel -REAn. 412773 P105676410T22 - Cap, Ste I 340.000.00 im.

~no .3908831975111 Faro .390383660824 T as 800 0135 209

Intablarmalabovit Web nww.lanualabor It

DOOM ~mi " ]

Hit.. Mbaarnol•O~bilabania si.

15•1•04rWAN 15.1•0111~

V.09 Pag.2 of 3 Pag.1 o( 3 3.09

n _

•

2 Z. *

: •

• . • • x ... c•-

z I- .2 .5 a.

S 2 ..!

2C. c

‘. "..

- -

- a 2

..9

2

z n

....,

rk

. . . . n — z

es e =

72: ...i

=,

s .

.

7- . Aia

E r.'; p

Ti .ir

i g

IN, 14 b% IA

n , '.3.1. ..,

g

.-

•

-a

te '. :.

•

— $ a A it 4 c &•-i51,Z2

2,e;.2q2s

A

c .21

4

.3

'-.

P O

n

1.,

.._

C' .' 1 n

22

C e E

IdS:1

710 .1X

ONII

IV

z. a

g

OR

IGIN

ALE

DE

L P

RO

DU

TTOR

E / M

AN

UF

AC

TU

RE

R O

RIG

INA

L C

oA

o