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STN7aPD CCUTBCl PPDCfDUBE

EAB 14ATE SPEC/PI?/CBS Code Busher: 0103043 Page: 1 of 2
[Dsee: Issue Date: 19-10-ll
| CitriO Acid Anhydrous
| Supersedes Date: 18-11-08

Prepared by:
Mealy barned, BBo. Chem.
lity Control Analyst Signatura:

Verified by:
Sherif Antes, BBC. Chem.
Quality Control Assistant l4snager

Approved by:
Amal Baafat, BBC. pharm.
ality Control or

Approvod by:
Assaf Fawaz, 880. pharm.
lity Control l4anagar

Spproved by:
Alas El-Gindy, Ph.D.
Quality Control Director

Approvod by:
~z Eamon, MS.Phafm.
Product Development Director

Authorizoc by:
Syed Imtiaz Baidef, Ph.D.
Quality Affairs Direotor

on for issue:

20-04-89 1.
16 12-97 1. Specification revised as per SP 93.
2 . Now EoTmlLt doveloZ>eqf Eoz raw material aPooiEioetiona.
3. Boasons for revision added for SCP histofy generation.

09-10-03 1.

21-05-05 1.

31-07-06 1.
18-11-08 1. Ravi.wed and re-issued for Citric Acid Anhydrous as per USP3O-
NF25.

1. Reviewed and ra-issued for Citric Acid Anhydrous as per USP33-

19-10-11
NF28.

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STANDARD CONTROL PROCBDURf

_______________________
RAW NATBRIAL SPBCIFICATIONS Code Number: 0103043 Page: 2 of 2
INT-o: Issue Date: 19-10-11
| Citric Acid Anhydrous

Molecular formula C6H807

Molecular weight 192.12
CAS No. 77-92-9

USP33-28

Dascrip on Colorless, translucent crystals, or white,

granular to fine, crystalline powder. Melts at
about 1530, with decomposition.
Free from extraneous substances like black
particles.

Very soluble in water; freely soluble in alcohol;

very slightly soluble in ether.

Clari of solu on The s- no clarity as that of water.

The test solution is not more intensely coloured

than standard solutions As B or C or water.

Water mT 1. 0%

Readily carbonizable substances Passes test

0.1%

0. 015%
Sulfa
0.001%

0. 036%

It contains NLT 99.5% and N]Iff 100.5% of CsHeO7,

say calculated on the anhydrous basis.

Microbial limit:
Total aerubia baatezial count MT 1OOO GEM|g
Total combined yeast and nould NWf 100 cfu|g

_____________________________________________________________________________
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STANDARD CONTROL PROCEDm:(I!i
Co N r: 0119009
RAM| NATRRIAL SPfCIFICATIONS Cads Number: 0119009 Page:
Paga:12ofaf22
STANDARD CONTROL PROCEDURE
RAW MATERIAL SPECIFICATIONS Code Rumba : 0101043 Page: 1 of 2
| Name: Issue Date: 07-09-11
| Avicel PH-112
| (MiOreOrystalline cellulose) Supersedes Date: 12-11-08
Prepared by:
Maaly Mohamed, BSc. Chem.
Prepared by:
Reference
Quality Control Assistant Officer
Mealy Mohamed, BSo. Chem.
Signature/Date: RP 2012
Quality Control Analyst
Molacular \night 294.1
Verifiad by:
CAS NO. 6132-g6-3
Sherif Abbas,
Verified by: BSc. Chem.
ality
SherifControl Deputy
Abbess BBC. Nan&gar
Chen.
Paratar
Quality Control Assistant Smcification

Approved by:
A white ar
Dascriptian
Approved
Amal by:
Raafat, BSc. pharm. almost white,
Quality Control
Anal Raafat, Nanager
BSc. pbarf:. crystalline
Qucal:i e:ii! Conb3::ol 34araager
powder Or white,
granular
Approved by: crystals,
Approved by:
Identifiaatian
Sheikha Zhamis, BSc. Chem. sli9htly
Assaf Fawaz, BBC. phaff:.
ality Control Nanager deliquescent in
Quality Control Manager
maist air.

anceApproved
Of solutian
Approved by:by: Freely soluble in water,
Alas El-Gindy,
Alas El-Gindy, Pb~D.Ph.D. practically insalubla in
Acidity Or alkalinity
Quality Control Director
Quality Control DireOtor athanal
9685.

Approved by: A. To 1 ml af
Quamruz
Readily Zanan, MS.Pharm.
carbanisabla substancas solution S*
Product Development Director 3(Irl 4 ml af
water. The
resultin
Authorized by: salutian
Soumah A. Qutob, MS. Pharm. givas the
Quality Assurance Director
8ulphas Signature/De reaction af
citrates.
Heavy metals

ason for issue: 11.08 - 13.Ow, determined an 0.3009 by the semi-micra

determination af water. After adding tha substanaa to be
13-07-94 1. First timeexamined,
issu . stir far 15 min befara titrating

say 12-11-96 1. 8odiurn citrate contains NIT 99.0% and Ntf[ 101.0%
09-04-02 Of
1. trisadium 2-hydroxyprapane-1,2,3-tricarbaxylate,
27-03-04 calculated with reference ta the snhydraus
1.
Microbial
22-11-06 limit: substance.
1. count
Tatal aarabia bacterial
29-10-08
Tatal combined yeast and
1. mauld
27-06-12 1.
MT 1000 cfu/g BP 2012 .
Note: lOff 100 cfu/g
Salutian S*

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ar
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autside Julphar
Julphar without
withaut written
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authorization from
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Mmaging Diractar.
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STANDARD CONTROL PROCEDURE
RAW MATER PECIFICAfIONS Code Number: 0101043 Page: 2 of 2
|Marna: Issue Data: 07-09-11
|Avioal PH-112
|(Mioroorfstalline oallulose) Supersedes Data: 12-11-08

Reference USP33-WF28 snd In-house requirents

Signature:

Parametar Specification_
Desoription Fina, white or almost white powder. It consists
Mrnager of free-flowing, nonfibrous paftioles.
Signature:
\\
Free fros extraneous substances like blaok
paftioles.

Insolubla in water, in dilute acids, and in most

organia solvents; practioally insolubla in sodium
Solubility
hydroxide solution (1 in 20).

Passes A and B.

Between 5.0 and 7.5

Signature:
Identifioation

NMf 1. 5%
pH

MT 0 . 05% Signature:
Lass on drying
MT 0.25 %
Approved by:
Residue on ignition
~z Zaaaf: , MS Phaff:. mT 0 . 05%
Product Development Director Signature: _
Water soluble substanoes mT 0 . 001%

Does not exceed that of water by aore than 75 HS/om

Authorizedsubstanoes
Ether-soluble by:
Syed Imtiaz Raiders Ph.D.
0.28 - 0.34 gm/om3
Quality Affairs Direotor Signature:
Heavy setals
NLT 90% should pass through 250 mioron.
NIT 45% should pass thfough 75 aioron.
Conductivity
Reason for issue:
16-10-93 1. First tine issued for Julphar-Gulf Pharmaceutical Industries, U.A.E. on the
Bulk density basis of USP NF and mT 1000 ofu
vendor's per gram
specifications.
22-02-98 NBff
1. Specifications revised as 100 ofu format.
per new per gram
2. sampling and tastingAbsence
instruotions added.
Partiole size analysis
3. Reasons for revisionAbsence
added for document history generation.
18-11-98 I. loss on drying limit revised as per vendors s speoification.
Absence
31-01'99 1. SPecification revised as per USP 23 NF 18 Supp.9 and vendors s specification.
AbsenOa
I. Specification revised as per vendors s specification.
29-05'99
Miorobial ii ~mits: 1. SPeoifioations based on USP 24 NF 19 (Page 2432 & 2262), MC specification.
02-05-2000
2. Reoommended
The total aezc>bic miczobial Preservesize
Gauntin-house partial. in tight Containers
limit included.
12-ll-08 1. Reviewed and re-issued for Avicel PS-112 (Microcfystalline cellulose) as per
USP3O-NFf5 and In-house reguirements.
2. in-house paffiole size limit inoluded.
1.
Revsowed and xe issued fox Avioel PH-112 (MLoxool;fotellSne cellulose) as per
USP33-NF2S and In-house raguiremfmts.

_______________________________________________________________________________
________________________________________________________________________________
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releaseoror
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divulge outsideJulpl&a&;
Julpbar without
with t written authorization
w& tten authorization frosfrom Managing
mnnging Director.
DlraOtor.
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Paof 2

Prepared hy:
Mmly Mohamed, B8c. Chem.
Quality Control analyst Signature:

Verified hr:
8hsrif s, BSc. Chem.
Quality Control assistant \\

Apf)roved Dy:
heal Raafat, BSc. phara
lity Control hon&gar

S1.gnature:

Apl;:Iroved hy:
also Sl-Cindy, Ph.D.
ity Control Director signatures

A;;q;:>roved Ly:
Onaaruz Zaaan, .Ph&rm.
Produot Davslopment Director Signature: ..

Authorized by:
8yed /arias `Reider, Ph.D.
Quality Affairs Dirsctor

ons ZOE issue:

25-O1-99 lo In-house microbial limit added.

O1 07-03 1. Updating for Xmthan Cum {Ksltrol F) as per current U8P Rf and
In-houss reguirsasnt.
13-08-05 1. Updating for Santhan Com as per currant U8P RF and In houee
reguireasnt in addition to particle size limit.
O1-08-07 lo Updating for Santhan Com as per U8P 30-aFf5 and In-houss
reguirsaent in ad,"1ition to psrticls aims limit.
29-10-08 1. Reviewed and rs-issued for Santhan Com as per USP 30-UF 25 and
In-house reguireaant in addition to particle size limit.
18-12-11 1. Reviewed and re-issued for Santhan Cum as per U8P 33-Rf. 26 and
In-house rsguirsment

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Codo : 0124001 Paco: 2 of 2

aSP 33-m?2e and Zn-house zeqluif -eats

Supplier Material Name Eoltrol F or Hootural 75

qmcifioation_
Croam-colorod powder.
Free fros eztranoous substancos like black particles

Its Bolutions in water ore neutral to litmus. 8oluble

in hot or cold water.
Idontification

Viscosi Tho vscosity at 240 is NLf 600 centipoisos.

Loss on drying It 10$OB mT 15 0 , of its weight at 1050 for 2.5

hours.

Tho weight of the ash is between 6.5 & and 16.0%

calculated on the dried basis.

Heavy setals 0.003,

Limit of isopropyl alcohol

Pyruvic acid T 1.5%

say It contains NLT 91.04 and mT 108.0, of Xanthon cum.

In-houso rodfl:liromont:

Particle size limit NLf 92, particlos pass through 75 um (200 Nosh) .

Microbial limit TM!: ffff 1000 ofu/g.

Free from 8almonollo species and E. coli .
Fungi count: NNf 50 cfu/g.

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SCONTROL PROCEDURE
Page: 1 of 2
________________________
STANDARD CONTROL PROCEDURE
RAW MAT1!!:RIAT" SPECIFYCA?IONS Code Number: 0103014 Page: 2 of 2
: ' ~ Issue Date: 13-10-11
| Sodium 7 )4FD (Grade X)
| (Carboxethylcellulose Sodium)
| Supersedes Date: 29-10-08

Reference USP 33-NF28 and In-house

Verified by:
SupPlier
Sherif material
Atd>fLs, nameChem.
BSc. Carboxyrnethyloellulose Sodium
srand Name:BIANoSE Cellulose Gum, ,Grace X.
Quality Control Assistant Bb3nager

Parlameter Soecification

Description White to cream-colored powder or granules. The

powder is hygroscopic.Free from extraneous
substance like black particles.

Solubility Is easily dispersed in water to form colloidal

solution.Insoluble in alcohol,in ether,and in most
Siature
other organic solvents.
Identification
Passes A,B, C tests.
pro :
pH
ma El-Gin , Ph.D. Between 6.5 and 8.5 in a solution (1 in 1001.
Ali Control Director
Loss on Drying
It loses MT 10 .O% of its weight at 105o for 3
hours.
AIProved
Heavy by:
metals
l2uamfuz Beman, NS . Pharf: . mT20ppm
basay DeveloPment Director
Product Signature:
It contains not legs than 16.5 % and not more -hen
9.5 % of sodium (Na), calculated on the dried
basis.
In-house:
Viscosity
The viscosity of solution 2% concentration is
Microbial limit:
Total aerobic bacterial count NMf 1000 cfu/g
Total combined yeast
1. and Would Ntff 100 cfu/g

24-02-97 1. New format developed for zaw material sPecification.

2. $amfling instruction added.
3. Persons identified for writing,verification, aPProval and authorization.
4. Sea.ona foz 2;eviaion added Eor BOP data hi.serf genera on.
S. crobiological limits are JulPhar in-house roguiremfmt.
03-0S-04 UPdating for M: Sodium 7 mfr (Grade X) as Per current USP NF and In-house
1. requirement.
27 11 06 Updating for CMC $odium 7 Nffl (Grade X) as Per USP29-NP24 and In-house
1. reguiroment.
29-10-08 Peviewod and re-issued for CM Sodium 7 Mm (Grejrh?I X) as per USP 30-NF2S a
1. In-house reguiroment.
13-10-11 Beviewed and re-iesued foz CK Sodium 7 NPfl (Grade X) as Per USP 33-Nf.fS u
1. In-houeo reguirement, with amendment in mi erof ial I int t .

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