F

GLOBJOUS
GLORIOUS LABORATORIES
Quality Control Document # Version No
0l
Effective Date
26-0.t-2020
Next Rev Date
26-0ct-2021
GL/QC/DF/0lE
Department
Raw Material Report

Material Name L-methyl folate GRII Number 1106

Batch Number EBMF99-090421 Quantiff 2.7 kg
Mfg. Date 04-2021 Exp. Date 03-2023
Receiving Date 21-10-2021 Reject Date 22-10-2021
Excellent Link/ Excellent
QC Number 9t5lRN1/21 Supplier/Source
biotechnologies
Specifications B.P 2018 Retest Date 20-t0-2022

Identifications:
Test Applied Specifications Results
Physical Appearance Pale yellow colored powder Complies

Sparingly soluble in water, very slightly soluble or

Solubility insoluble in most organic solvents; soluble in alkaline Complies
solutions
Water content NMT 15.0% NiA
Assay 97 102% tlt.5 %

Remarks Release for production use.

Name: Zahid Ali Name: Amjad

Desig : QC Anal st Desig: QC age
Sign: Sign:
Date: Date
 .-'"/'r
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<-\- -/
\ ExcEllrrut
E"og'
^-,.adrd
clittTlFtcAl'E oI' \N,\l-\'Sl\
Produ(l \r$e :lli.th:..lfohte Crki$ln
Brrch \uflb.r EB}l l'!',.0901: I \llg I)Nrc \pr,2021

Qulnril. lt) kE \lrr,l0.lJ

SI \D, It<\ u lr. li[)ir\

Palc \cll0\{ (olor l'o\tder vthire to Pale Yellow colored powder

l,l.,rlrl-r!!l(,rr Il\ lltl 5:l1xplu Il{ sp..lrx ii !onrrr!!rlt \rLilrrhi:r Speclrum con\i5ltnt \ itf mlttur}a.' -iptrrrum

] ldrnlrllcmon li )r cfllctunr Solurion ofcalcium 56Is formol irl\oluhle \ollllLioli:.1 cili.rrrnr sillrihxl:J .r.r rntolub
o.\&l8tqr

I'dni.1. Si?{- f\ I tl)

Pffiiclc Si?r.Dl50) 1192 970 r cron

Iitl'li(it Sr/r lXq0)

llulk l)crsfl r -t lntafird Report resu ts

ttulL t)en\rt) - lhpp.'d {)56 girrl

Chemr(al Paramerert

Idqrdrlidrorr (B\ HPLC) lhc rctuuiorr tiruc ol Lhe rnator pcsl in dlc
chronrologrunr Lrl pr{.'pdralrorl $Jrrcspol
^ssa)
to lhar in tlw chrunrxlegram oi'Jrc sturdard

prrTaratioo. ns obt0inf,d in the lssu*

1a \\ra!cr m,rte r (ll\ KF) t4 a% Not more than 15 0 % w/\tr

1r \or nroN rh.1ll l(l ppD)

i2 7-0 -"/o r(, 8 i. o/. $J\

1l l)rdl !n!]u.t^ iiJft.n%) 2{'ln Not trxnr rh r 2 1 "-n
=
t,1 0 !t,roit tos) \dr arore lhan l0uu
l5 A\$) ro," \! \ nn .rnlrlJmus hiai\) 990% 970 1020%
rll\ lll'l r'l
I'urrr (Ll\;lPL(

17 IAMC II \,,1 .ir,,r! Lll.ll irxr ( I I

18 r\'\i( < l0 cl:L-:ls lhtyl ll')a t'
t9 I colr {b\anL I r.l'! Sh.,irld hE.\brcri ll) r
t0 \horld t\c,\.'rrflr l1r q
21 l's.udonlDn.N .rcr!g;1,,]Lrsrl Sh(ruld hr,\bscrr. l0 !
5r.,!h\ orr..ui rur(nt Slrould beAhs r 11l !
Condit;on: Store n; .lo5ed I ht r€5rstant contarn

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Plt,t No, l2ll2, Sy No.r?2, Kariyappurro H lli, Junglc Prlya Gate, JiEaDi Rosd, Burnerghatta -Po.
BANGALORE 560 083. Tel: OO91-80-421O9a77 /89D4857846, O'maili inlb,rexcellcntbiotech.com
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 GLORIOUS LABORATORIES
Quality Control Document # Version Etfective Date Next Rev Date
GUQC/DF/018 No.0'l 26-Oct-2020 26.Oct-2O23
Department
Raw Material Report

Material Name Pyridoxal-5- Phosphate GR.ll Number 1205

(Vitamin 86)
Batch Number 8D211102-H 25 Kg
Quantity
Mfs. Date 10-2021 Exp. Date t0-2023
Receivin Date 23-12-2021 Release Date 23-12-2021
12t0lR.\,u21 Supplier/Source Infork International
QC Number
lJ ari
Pharmaceuticals. Co
Specifications B.P 2018 Retest Date 22-12-2022

Identifications:
Test Applied Specifications Results
Physical Appearance Slightly yellow or offwhite color powder Complies

Very slightly soluble in water; soluble in alkali-

Solubility OH-Soln; Almost insoluble in ethanol, acetone , Complies
Ether, Chloroform
Identification Must complies: Complies
Absorption maxima 288 to 296 nm
Melting Point 140'C to 145 'C 144'C
pH 2.6 to 3.0 2.71

Loss On Drying NMT 1.0 % 0.41%

Assay 98.5 to l0l .0% 101.47%

Remarks Release for Production use.

Name: Zahid Ali Name: Amj ad Khan

Desig: QC Analyst Desig: QC Man ag er
Sign: Sign:
Date: Date
 A d,*rr-iq6rdf&xrl
lxri PhxflrLrrculrt:rl (i, LIJ

iltfrWfi. Ccrtificate of Analysis

l! ll, {4.{lti./Product namc

llt l..l
'Batch No 300kg

ll,P ll lUiManufacnling date 2021 t0 27 Utj(i I l.llJl/ltctcst datc 2021 t 0 26

,fi,) g(i ll JtJJiAnalysis date 202 r r r.05 CnS No 4 t468-25-l

|l .Y;.i4r ilii,'Refcrence tt fii f,rillil/ tn-houso J',rr;lt t;7Y"rr,ou ,o BD-A-r 00

4 ll /Tcsts E litffi I|USpeci fi urtions 4.llVRcsults i lNleahod

i! N'&dXu tr#)..ii
?I+il .'i 1 ,(,'iJY sua)
fl'W,tppcatancc Conforms
Sliehtly yellorv or ofi--rvltite porvdcr

A l-1 +ai)f i:,li, rrjt. t-,1/F x,J llti rH, ri''J 4r. rl. )t iif -
Ur 5*" f +*il;t IR
A. The lR specrum ofdre sample Conforms
correspends to that of the Refeneoce standard

,EBJ)
B 5 f,jiif:,il fi .I..ff xfl lfi ii ff'J 6iif Jrli+{*B
Idcntification tr.f til
-t"{"
}IP B The reLenlion time of the major peak in the {+trtfliil
chromatogram of the Assay preparation HPLC
LC Conforms
conesponds to that in the chromatogram of
Standard preparatiorr as obtained in the
Assay

+N v4 /K' lii 1' (fu w ik'

iii + ) L.y' 4' rii' l' Lfii, 11

ffi. aft.. iil{, ?+fi}.yi .Plitillvisuat

l#h4tUsotuuitiry \/ery Slight soluble in waterr solublc in alkali-Oll Confomrs
Soln;Almost i-nsolLrble in ethonol' acetone' Ether'
Chloroform
Ch P Appendrx
t40.0'c- 145 0"c 43 0"c
lErS/lrletting Point r
VIC
Ch P Appendrx
8.6Yo
fiAN'ater Content
=
to.0% VIII I\,I
Ch. P Appendix
PH 2.6-3 .0 28
VI H
r+alr.f,r Ch. P Appendix
f,i&/l'article Size D (65) =\OU/u D (80) >60% Con lorms IXE
0 339/rnl usP<615>
fASElButr oenslty
KB;8[/l spped Density 0 669/ml usP<616>

<l0ppm
Ch P Appendrx
8.ft,8/Hcavy Irlctnl < lOoonr vtII fr
r[ ),f/tulethylberzene ! 89Oppm N/D CC

II tsii?ifitllnesiouat Zh7lEthanol 5 5000ppm 46ppm CC

Solvcn ts
.iL 1- FiJn-Butyl N/D GC
5 5000ppm
alcohol
i$;i!
,Uil/Addrcss: 'j,lCiIri:'fr rliJt?ft$ 9 t!19 X;anfcng Road. Lianl,ungang, Jiungsu. PR China
ttli!,hlP.C:222069 tuiJirlcl: 86-05 t 8.t5 I 5230 I {tl(/Fax 86.051tt-t15152761 ti2
 3 iL * it
lnri
.a rt 6 jL d l&'/l
Ihlrrrxecrrli$rl( (t I l(l
d]

'rltfr-W5 Certificatc of Analysis

lt,11i, l', ftilProducr ncrnc {iiti fitlllt' lr, |lf / l)l,rrdoxal 5-phospltatc nronoltydrnttr
.lll, lrilBatch rlrrarrlity 3{)0kg
llt r..i ,'Batch No BI)-l I l r0ll.l

'i-,s' I I JtJliN4cnutacturing datc 2021 l0 27 U lJj) I lJUl/lt0tcsl datc 2021 t 0 26

()\S ,l1468-25-l
It tji I I lUli tnalvsrs datc: 2021 I I 0-5 No

7>' 4 l,r; ili:.'Rcltrcncc lr1 l:;: l,ti?lii/ hrlrousc ;i1j.,Jr l.|-i Vcrsion No BD-A- r 00

4Enests }n [tEi XlTS pcci fi cat io ns 4irVRcsults )iltttq.tnrro

lillti trrr.,', S ) 5ltPnr <0 040ppm lC P- lvl S
"
.c*^tr 111'Lcad ! 0 5pprn '(0 lppnr IC:P- lvl S

Elcnrcntal I nrpu rities fi'fr/Cadrnirul S 0 5PPnr (0 0l ppn: lClP -lvl S

,k/i\4crcur r-,
S0lppnr < 0 0lOppnt AAS

fffit!{ s 1.0% 0 37% usP<73 I >

Loss on Drying
<050% N,t) I IPLC
Pvridorine llCL
Ch. P Appendrx
i'.i:i i+,',i'. trk,'rotat Platc Cou'rt S I 000cf!/g < l 0 clu/g
XIJ
( Ch P Appendrx
fif {t};T1l li;i i'ij dtl y east and lr,lold S I OOcfi-r/g I 0 chr/g
XIJ
Negatrve
Ch P Appcndix
i'-L'l'-l R iH/Sa.hnonella SPP N/D
'ily+Z fnw XIJ
Ch. P r\ppendrx
ll icrobiological Tests )1!hl,l'lfi/ECoti NegatiYe N/D XI J

{r; irt C, ttiiTdj t.li t}i Negatrve

Clr P Appendrx
NID
Sta h lococcus Aureus
\IJ
Ncgative
Ch P.\ppendir
/<lli1'l: ifi lillCol iforms N/D xtJ
,i!l (lfift7y.il) 99.3ya HPt-C
98 5"h-10t o%
Assay (dried substance)

**:t.t*,Pfn?'tdflffi*,i"
Conclusion: fhis batch ofproduct confornrs to the spccificatiorr

Q,\ 4!JV QA l\la el.,i

.llit/,q,ddrcss: ,1,
l1,lil: rj:A',1 ,iiU il, Jt ff ffll 9 Lrlg Xartcrrg Rold, Linnyuugtutg, Jinngsu, PR.China
tlfl*ilP C. 22?t)69 tU iItll'el: 86.0518-85152301 ltl[/Fn\: 86.0518-85152761 212
 F GLORIOUS LABORATORIES
Quality Control Oocument # Version

Department GUOC/DF/0'r8 No.01 'Jl"slt*rf"im:,:*

Raw Material Report

Material Name Vitamin Bl2 GRll Number t715

Batch Number c2r0s2tD Quantity 0.7 kg

M Date 05-2021 Exp. Date 05-2026

Receiving Date 25-10-2021 Release Date 25-10-2021

QC Number 93stRMlzl SupplieriSource Ali baba chemicals /Hebei Yuxing

Bio-Engineering Co.Ltd
Specilications In house Retest Date 25-10-2022

Identifications:
Test Applied Specifications Results
Physical Appearance Dark red crystalline or amorphous or crystalline red powder Complies

Solubility Soluble in water Soluble

Loss on drying NMT IO% ].l00h

ldentification A UV: the absorption spectrum exhibits max at 278nm, 36lnm, Complies

5 5Onm

Assay 97 ----- 102% 102.3%

Remarks Release for production use.

Microbiological analysis:

Test Specification Results

TAMC <1000 CFU/g l0 CFU/g

TYMC <100 CFU/g Negative

Name: Zahid Ali Name: Amjad Khan

Desig: QC Analyst Desig: QC M
Sign: Sign:
Date: Date
 fl)tr-a++nt fEa[R2\a
HEBEI YUXING BIO-ENGINEEzuNCJ CO.,LTD.
l1!tL ,"J ltAt #t+ ffiir{11 Add xi(h.Dg Disrricr.Nirgtin (ounr}.Heber Pro\rnce.China

Certificate of Analysis
Pffi&&ffifr8
PHARI\4ACEUTICAL RAW IVIATERIAL
CONTRACT NO : 111 OCT 4054012021

Product name VITAMIN 812 Manufacturing Date May 18.2021

Batch Number c2105210 Cert Date May 28 2021

Packing Ol KG/TIN T OOTIN/CTN Exprry Uate May 17 2026

Quantity 1O OKGS According as USP 43 and in house standard

Test items Specifications Results Test methods

Dark red crystal or amorphous or
Characters Complres Visual method
crystalline red powder
UV The absorption spectrum exhibits
maxima at 2781'1 nm,361 t1 nm,and Complies USP monograph
ldentification A 550t2nm
4361 n6/A276n. 1 70-1 90 186
USP monograph
Asor n,/Asrz,ssgn.:3 15-3 40
ldentifrcatron B Coba t I\4eets USP requrrements Complies USP monograph

HPLC The retention time of the major

ldentification C peak of the sample solutron corresponds Compl es USP monograph
to that of the standard solutron

USP
Loss on dryrng <10 0% 2 1a/o
monograph/U SP<731 >

Assay 97 0%-102.0% 99 10/a USP monograph

Total impuritiess3 0% 14%
79,88-Lactocyanocobalamin <0 7% 0 6,/"
34-Methylcyanocobalamin <1 5% 0 20/o
Reiated substances USP monograph
8-Epi-cyanocobalamins0 5olo 0 2"/"
Any other unidentified impurity and
50-Carboxycyanocobalamir\32-Carboxyc <Q.2o/o

anocobalamrn s0.5%
Acetone <5000ppm 57ppm ln house/(GC)
The total aerobic <'1ocfu/g
<1000 cfu/g chP<1105>
microbial count
The total combined chP<1105>
<10ocfu/g <10cfu/g
yeasts/mould count

Conclusion:The product complies with the specifrcation of USP 43 and in house stan

+
l(