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Page 8
I111; ,711wpnr
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Toliriant-ArTlirtrilu 30 Will
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nailflIalibt11111Z140
2. VJWIZIRDi1J70J/J10-u,-ntrmeZviErlo-arvanint-wPign-nirii1urawaviErt1141111WEJ`101,aumnu
3. ilw:t-lgaiine,Imw-5---a5it-IT-ff.A-liltfig-ana.tii-aod-wiltninguanUIi-1"11-13'Y -571-15'-r-r"12.11t7'115.111?
4. trifiLffuotAltuiciuilTholuqNRvmiaLfluerwrivAlvilOu'lquqm (AT) -------'-)-' 1.1-,711-ct:i.Tm-zuin.
(.FOila) -14, .... .. n.5-75.in
T,,,,,, 2:1--,,.z\r,)(------- (.R4-iio)
5, `-/ 0
Tlflq
,TE/V;;InifiTinJ;
Page 9
e1"
/-"
Ilim a AnIpa+‘,.--...)
1,{.;15:.r5riangparil Srathonge?1)
hifoCard !4tirnber(2..F1V1-FCC-CC,21-12:15 Effectivf2le21 Sep 2015 2:20 F' 1
ertin . - Berlin Pharmaceutical Industry Co.,Ltd. 222 Roniklao Road, Bangkok 30520 Tat. 0-2737-6717 Lax. 0-2360-8730
CERTIFICATE ,OF . ANALYSIS _ . ..., . RAW' IAL.
'
•
Product c.ary,edilol
Product Code 10-224-0 .
. c-rx Li fesciences (P) Ltd. 688 anufacturer . Control Number 16R0 M
Original Lot No. : 1601000032 Supplier : Science Plus International CO, Ltd. ... .
Lot Size 7 x 20 +10 kg Manufactured Date 01/07/2016
Invoice No. P11608/026 Expiry Date 01/02/2021
Receiving Date 05/08/2016 Analysis Date : 25/08/2016
. TESTS. . .
REQUIREKENTS _. -.RESULTS • ,
Description
Solubility
Identification
Assay on dried basis
Impurities
Residue on ignition
Heavy metals
Organic Impurities
Carvedilol related compound E
C'arvedilol related compound A
Ca AteoilolI bisal. vrocattec_hol 41,
dIglin fppis nil 161112J196AtIOMI-1491V1917
CarVedilol related compound C
Carvedilol related compound D
Carvedilol related Compound B
Any -other individual impurity
Total impurities
Specific Tests
Loss on dryinr...
White'or nearly white, crystalline powder
Slightly soluble in alcohol ; practically insoluble
in water and in dilute acids
A: Infrared Absorption
B: The retention time of the major peak in the
chromato.grarn of the Assay preparation
corresponds to that in the chrornatoram of the
Standard preparation, as obtained in the Assay.
98.0 % - 102.0 % of C-4-1-N-,04 - 1
Not more than 0.1%
-Not more than I 0 ppm
-----P Not more than 0.1% nlf,j@... . ......... ..... ..... Not more than 0.1% A -ft-- v qts, ipcv->"La Not_ rnere.thA (19154 1 u '-'•• --,••' --;•• *
infll 4 1.71a- ..... .... . ........ . - Not more than 0.02%
di Not more than 0.1% al'uo Not more than 0.1%
Not more than 0.10% l(-.) kkLC\t'"‘
Not inure than 0.5%
1̀ Ali? - 91Y5-0111JOM-1 111GISCIfIDDVIWC1̀ 91
Not more than 0.5%
White powder
Complies'
'Complies
COMplies
r.
100,1%
0:0,1%
----- 10pprn
. Ir .,r,at,468 0.027%
v 0.009%
—411115 0.000%
...rarru . 0.00% .. -.
1A1F1-11J 0.015%
0.012%
0.010%
V 0.065%
tinq ., .
'II) i 7%
Status
Rema rks
. e. 4-.r r5. (‘‘ j X j Approved 1 I Rejkc91..c g,
„--., • „'•11 r-,:z, ,-,,q; ,,..,,,•cs. rP c,' 1., ...''S 6
c''., \ cY'') * ,5-0 .. fisZY° -• ' _ r,q'''
Viy
Page 10
Date: September 9, 2014
TO WROM SO EVER IT MAY CONCERN
We, CTX Life Sciences Pvt. Ltd., Block No. 251-252, Sachin- Magdalla Road, GIDC, Sachin,
Sprat — 394 230, Gujarat, INDIA hereby declare that Carvedilol Related Compound-F is not
possible to be generated based on the route of synthesis followed for manufacturing of
Carveditol YJSP drug substance.
Sincerely,
For CTX LIFE SCIENCES PVT. LIMITED,
ifa ONDAL V.P. - Quality Assurance and Regulatory Affairs E-mail: imitznofdal0,etx.ls.com
BTU
LimMIthfinciikpa6wi'vrofiriififl ••••(4,11111
MEM
li3.1719
DAL-Arvx\r'-
Vv*..
........ . .............. ..
....
..... ........ .... ....................................... ...............
TITZ•.%:11-1'17
!, Al'O .......................
................................................ ;1.11-1—%
s Pio! No. 2:7,1-2.52, : 02e1-239.966,
":• f<cA - Road,
Roe,6, GIDC, Sachin, - C.3ujara i, INDIA.
02:5-i-2398547 • Webs4 : Gujarat,
' t ice' 2E97800 I 2897801
Page 11
Pre eared b Checked by Approved by
Chhatrasinh Girase I Hemaiit Patel Chetan lYlodi Assistant- QA Sr. Executive— QA Asst.. :YI2-, n n ger __QA ,.-.V
VVorks'a.t: MX L1fe<r-i4.-nrr,c flal T#4 111,,,i- 'NT,- '1:-.1 or,-) c:-,•,-..:.„ T, .1"- - .4 I T TT - .--I -',1-Y ' GI DC Sachin, Dist: - Surat (Gujarat) India. TE +91-2E -J-2- 9.96. f ±9:1-261-23.9.7
- - -
Pa-0e. of 2 Cl:I,' tCA. .. OF A ..v.c;15.-:
PRODUCT: CARVEDILOL USP 37 -
Batch No. l6C100003") .., R. No, : F01600971
Mfg. ID#e July 201-6 Quantity Supplied 150.0 .Kg
Expiry Date : February 2021 Date of Release : 20/07/2016
S.No. Test Observation Specification adsmption —White, crystalline pov,der. White or almost white,
crystalline powder. 2. Solubility Practically insoluble in water
and in dilute acids, slightly soluble in alcohol
Practically insoluble in water and in dilute acids, slightly soluble in alcohol
Identification A) By IR lR spectrum of sample
recorded as ATR exhibit absorption maxima and minima at the same wavenumbers as that of the IR spectra of similar preparation of Carvedilol working standard.
TR spectrum of sample recorded as 103r/ATR should exhibit absorption maxima and minima at the same wavenumbers as that of the IR spectra of similar preparation of Carvedilol working standard.
B) by ELPLC The retention time of major The retention time of major peak in the chromatogram of the sample solution corresponds to that in the chromatogram of the standard solution, as Obtained in assay.
peak in the chromatogram of the sample solution corresponds to that in the chromato,,rain of the standard solution, as obtained in assay.
4. Loss on drying (%,.. /w, at 105°C for 3 hrs)
0.2,4 Not more than 0.5
S. Heavy metals (%wfv.r) Less than 0.001 Not more than 0.00 6. Residue on ignition (%w/w) 0.02 Not more than 0.1 . Related substances (%v/,.v, by HPLC)
Carvedilol related Compound A Carvedilol related Compound B o od Carvediloi related UM) LJOI Compound C Carvedilol related Compound D Carvedilol related Compound E 4-Hydroxy Carbazole Any unknown impurity Total
Below detection limit
./ e 0.01, .., i 00, a1411111J11101t10 61 011fir(011
0.002.
0.01
Below limit of quantification Not detected
0,01 0.04
Not more than 0.1
OP- •
'11N1,4 -,,,‘ ,,,---ko ,,, Not morel i•0:02 ••••••,,:"
.4 —
Not more. t na:n u. i OI/10..„-- , —
tAl A me ._ . ... . Not more than 111 Not more than 0.10 Not more than 0.10 Not more than 0.5
Page 12
K CERT CATE OF ANALYS r2p,e f , f
PRODUCT: CARVEDILOL USP 37
E32tch No. : I 6C i0Ono3 -, - i 1 A. R. No. : FG1600971
Mfg. Date July2015 1 Quantity Supplied : 150.0 Kg
Expiry Date Feb_olar_y_2021 .
Date Release of .: 20/0W2016
S.No. ' Test I Observation { §pecification _ Residualsolventilg,by G - -- -C}
Ethyl acetate Methanol Toluene N, N-Dimethyl fou amide , Isopropyl alcohol
233 Not detected Not detected Not detected Not detected
Not more than 5000 Not more than 3000 Not snore thah 890 Not rnore than. 880 Not more than 5000
. Content of Chloroform, Benzene and Ethylene dichloride ().ig4 by OC-PIS) Chloroform Ethylene dichloride Additional solvent Benzene*
Not detected I Not detected
Not detected
Not more Than 60 Not more than 5
Not more than 2 10,Assay (% w/w, by HPLC as
C2,1-6,N0,1 on dried basis) 99,4 Not less than 98.0 and not
more than 102.0 Additional Tests as per customer requirem 1 ii, Particle size by ivialvera arm)
D (v, 0.9) 6.5 Not more than 10
Benzene is not used in process, Since it may be probable contaminant of other process solvent, the limit of residual Benzene is incorporated in the COA.
Remark: The Product Complies with USP 37.
Q., 11 a7l1'1 tuantlithi'lagflud61.4ovc,15
c4)-kiAPI (̀ r̀ ............
1131T1111.100111a11191koagwiffoiilfTh "‘k:IC'73 *211115 al#E) vi
M65 arc)
'INEY11!
Prepared by Checked by Approved by
7 tr I t17 li.- ! 1 ______ Chhatrasinh Girase Reptant Patel Chetan NI cl,di A 6
Assistant - IA Sr. Executive— IA Asst.,;) : a-v-1 c
QA \ ,, Works at CrX Lifesciences (P) Ltd. Block No: 251-252. Sachin Magdalla Road —c-^,K) \ <,-0", _ GTDC - Sachin,. Dist: - Surat (Gujarat} India. Tel: +91-261.-2399669, favv0281-23985
A01 ..........
.....
Page 13
Original Lot Number 16C1000032
1131711 LIJOn141^11i'11711i1f10flEllii'VVII
fivrtna
..• •NIEJ111
tinw ,„- INE,1111 ,0A
-e‘r s.;?, r,5 N
t-si
El
ii.m4t1NrioVi*Doll tom
08 aiztu NrIti"ifyivu v., 2559
11.1-.1H5i4i4ffrivIR.279,3olilti;9wrvti*Pil (Raw Material) la4g-lty9WitTeN +41-197.141uo
terwW1 (Trade }lame) CARATEN 12.E 0,0) ;1001114 (Generic Nan) Carve0i101 UO,BP
Lot Number 'A,101
1603043 ji
g41114.%141154C711
Control Numbtr UD4 Rau' Uateriai Original Lot Number V64 Rai( Naterial 0.0.50.nporisiu
16Rp6as
1 6C100003 2
1. lu Certificate of Analysis ti84 CARATEN 12.5 a(0) Lot Number 1603O43
2. 'l Certificate of Aaalyaia RE? laterial 904lia41V1 Carledilol
Control Number 1600688
3. 1.1, Certificate of Analysis Raw mte ial w4w4i"fislAu Cam . ' 1
Pt 4.40
pv,
•
Page 14
[XI Approved Rejected
:so 'Da 12_0g (kfs.Pcz-v.,een..a Porawarar_-̀ h)
e3 iC-` toty, t77
. , LW (MS 1: 1
InfDCard Dat,301 S.?.p 2015 ,.2:00 AM
BeaL Ber Ph lin armaceutical Industry Co.,Ltd. 222 Romkho Rcad, Bangkok, 70520 0-2737-6-717 Fax_ 0-2360-8730
CERTIFICATE OF A_NALYSIS
Product Name Caraien 1") 5 Registered Number IA 21150 (NG) • i s
Lot Number
Lot Size S.R. No.
rie.m-ipfion
000150 Man I I V.
1603043 Espiry Date 18/09/2018
1 ,0 '10,0-00-Tnlets A n al'sis Date 2g109/21ET1-6-7- 30/09/20-16 1603043-Fs-5258 ,.R. No. 160304_-Fs-5258!0
Orange round biconvex tablets with scored between "B" and "3" on me side and scored on the other Content Each tablet contains : Carvedi101 12.5 mg
TESTS REQUIREMENTS RESULTS
c.
Not more than 15 minutes
At Thttrt-..tcrittion time of the Major peak of the
Sample-- solution corresponds to th r. - he. at. oe.
Standatd Solution,: as obtained in the Assay.
B: Ul rat inlet Absorption
2 rain 55 sec
Complies
Complies
Disintegration time
Identification
Assay
90.0-110.0 `101LA 100.4 %
DisSolution (Test 1)
UnifOrrnity of dosage units
(Content uMfot-rniry)
Impurities (Or.3.attic InlpiLrities)
or
unspe.cifieci impurity
-Total impuritiats.
Not less than 80 %(Q) LA
s dissolved in 30 minutes
To meet the rtquireffients
Acceptance : Max 15.0 (L )
Not more
Not more th.-th . 1,0"a
Rinimu:74 va!ue ,
101.4 %
1+ hie 108.%%
5.6
0.000 Va
0.000.%
1l 1°rJ11 1-tio‘renalifarqsAnD614,4 TIfiq -
woMalii'incyjkoa.arrviiiffi
.4 v MI R Getir.OtI
.1';8 0 — Wail •
alto IN EJ
Status
Remarks
Analyst
Page 15
ilmivl 1,5111U-1111fl
A '-itlf1111,1 cri
Carvedilol e1§3.& mg tablet
71A1V1@9ithE1 (11191) e.&0
cancu (6im) 5`1n' Tni (`U 1Y
`'llnivl5rt4,1
215t1J1 lDo,000 G),odo,000.00
IAIT:111/151Y-11(1 0 0.00
1114@€J d,boo 61),1.9oo.00
V161110 o o.00
clj'llIVIL@ o 0.00
mnin @),000 ,&oo.00
illhlhnIL o o.00
)11M6601 boo 1D,s9loo.00
LeraiLQInunris51 do 1 0 0.00
Va161,fl 0 0.00
Vi`U@1666211 0 0.00
1111,1@lIO1d o o.00
`4.1411,15VTh7ttli Im&e,l000 e,ecno,eoo.00
'11,173clini1101
1int1111,n61 t90,000 0),Q1Dc000.00
IhnLnlo 0 0.00
11'11f1TJEJ o 0.00
1̀,v1517@a o o.00
1r11`6'211@1 1D,000 o)od,000.00
cUilivinj o 0.00
5quisrviivn.lucvne bele,000 o,bun,ocio.cgo
ilviimunn.riun
UMITIE.01 o 0.00
1711,r0 0 0.00
@lRiji114 o 0.00
ciJin94 0 0.00
7a519"159lifit.inVToun ______
0 0.00
ai 0 ni-nAlifinelgifiD&6414k ilmioctivpisiii zi48..,......„.......................4 uC iiiITTI
liy11-inil AZ -T° ''c' AY-11:4115 0 0.00
6'0,)1). ,1 Plth....... ---
0 Iltilla
0.00
RZ11,1M1 A (1..c- 0, bo,000 do,000.00
: 011'1114
Page 16
ill/0'o 11olErrty-la
A 71E1f117Y1 cn
Carvedilol ob.& mg tablet
71f11S1OV19hEl (v111) e.&0
cifillifli (iiwl) 71n1va (vim)
1111!@16Fi@ Q611,000 &d,&00.00
''Inn-i 0 0.00
awiiiqLui6 G),000 boil,&oo.00
cli5VraPEI 6110,000 ogn&,000.00
aminn 0 0.00
M4114591`0111.15111 6.11,000 cri&o,000.00
ilmioani
l'rruviii 0 0.00
INTL'IllY1EJAWIYIt o 0.00
iii111 0 0.00
6i-Ie116 0 0.00
Timml 0 0.00
I(1neia151 0 0.00
WIMg), 0 0.00
7Za11,n1lni 0 0.00
`Uf11J1t1161 0 0.00
mT,Itafi 0 0.00
vrt.alli-al 0 0.00
luismioalArie 0 0.00
"11)liclalifit9i
Alvi0 l9o,000 o),odo,000.00
Vili'll o 0.00
i'lE.11111Tbi1A o 0.00
11111.,1 o 0.00
1/171,124 )o,000 &,000.00
Unlilli" Go,000 C2oct,000.00
7q3.1i1V1'1911914111 crieo,000 0,&Gin0,000.00
ilVii911^M-01760q5Erl A
ONSEll plAn "4.)c\34? ........-......"-- ano.......01: • v .ir iiiiii rtivva
-'3 eivlitinGrivil,doo ..
ilioehithillicigfinglith o)bc,b&o.00
vill3@ A wita.......4 /
o o. o0
UllinU di 0 0.00 MITU.... ........., liti Ill
0.00 11111175 o
aer C1/ 011
Page 17
ilviiV1 1711AIEJTUla
A 518f117111 cri
Carvedilol elgn.& mg tablet
7init1owtho (vim) e.&43
%Manna (6U) 7-1f117'41 MVO
11'15111 ca 0 0.00
1J-1111g-iv% b,doo eno,boo.00
vollacu 0 0.00
cilmumn 0 0.00
mil 0 0.00
L11115111 o 0.00
111'1@t1 &,000 lDb,&oo.00
Len.n G)00,000 &0,000.00
Trio 0 0.00
CJ 1vi 0 0.00
aim72via-A 0 0.00
miLk1 0 0.00
TaJi.11/15911415Z,14MA@EISEJ1 aed,&oo beilm,ell&o.00
'11/1:191d-111(101
41111@1 b1.9,000.00 bs910,000.00
ITItVIN sn&,000.00 @)&gil,&oo.00
1011_4 0)691,000.00 db,&oo.00
'dildn 0.00 0.00
La-Awl 0.00 0.00
eraiV 0.00 0.00
11Au 0.00 0.00
722.1i1145fid111/101 aoe,000.00 &ecn,000.00
'22-.1 ilViiVI --.7,1111/-7— opob,doo.00 &,ecno,a&o.00
011141@:D.Z-M-....:11AV
4.1c?" 1.131711 Luoi"Suidifinctiinadiviiird ......
11Zi114
