Вы находитесь на странице: 1из 1

VERITAS PHARMACEUTICALS LIMITED,

ffBritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh

s PECTFTGATTON (RAVU MATERIAL)

MaterialName Microcrystalline Cellulose 1 02 BP/EP Code No. : 1113005


Document No. sPEC/E/1 1 13005/01 Version :
No.: 01

Superseded Doc. EM-0812 lssue Date : 02Feb 2014


Reference BP/EP Review Date : 01 Feb 2017
Reason for Revision To change the Specification No.

Storaqe Condition ln an airtiqht container


Test Procedure Ref. TP/1 1 13005/01

Tests Specifications VPL Specification


01 Description White or almost white, fine or oranular powder. Same
02 Solubility It dissolves completely in ammoniacal solution of Same
copper tetrammine, Ieaving no residue. Practically
insoluble in water, in acetone, in ethanol, in
toluene, in dilute acids and in a 50 g/l solution of
sodium hydroxide.
03 ldentification A. Violet -blue color develop. Same
B. deqree of polymerization is not more than 350
04 oH 5.0 - 7.5 Same
05 Conductivity NMT 75 uS.cm-'1 Same
06 Ether-solublesubstances Maximum 0.05% Same
07 Water-solublesubstances Maximum 0.25% Same
08 Heavy metals 10 ppm max Same
09 Loss on drvino 7.00/o max Same
10 Sulphated Ash 0.1 % max Saine
11 Microbiological Total viable aerobic count not more than 103 Same
Contamination/g micro-organisms per gram and with a limit for fungi
of 102 per gram, determined by plate count. It
complies with the tests for Escherichia coli, for
Pseudomonas aeruginosa, for Staphylococcus
aureus and for Salmonella
12 Bulk Density : Without 0.28-0.33 g/ml Same
Tapped
'13 Pa(icle size : 60 mesh Retention NMT 8% max Same
200 mesh Retention NLT 46% min
Form No.: VPL-QC-01 3-02/01

Prepared by Checked by Approved by

Sign & Date \%."-\ J


<o/ 6V t zt
d?*J,,^
Name Md. Monjur Rahman Md. Tarikul Islam Bossunia Md. Moniruzzaman
Designation QC Officer Asst. Manager, QC' QA, Manager