CORAL LABORATORIE LTD

ISO 9001:2008 Certificate No. IN015692

No.: SPE/RM/MC19
RAW MATERIAL SPECIFICATION
Revision No.: 00
QUALITY ASSURANCE DEPARTMENT
Page No.: 01 of 01
Material: Microcrystalline Cellulose BP
Effective Dt: 01/12/19 Review Dt: 31/11/21
Supersedes No.: NA Supersedes Dt: New

Reference: BP 2019

Sr. Specification/Limits
Tests
No.
White or almost white, fine or granular, slightly hygroscopic
Description powder.
2 Practically- insoluble in water, in acetone, in anhydrous ethanol, in
Solubility toluene, in dilute acids and in a 50 g/L solution of sodium
hydroxide.
3 identification
The substance becomes violet-blue.
a. By chemical Test

b. By polymerization The degree of polymerization is not more than 350.

Solubility Dissolves completely, leaving no residue.

5 pH 5.0 to 7.5
6 Does not exceed the conductivity of the water by more than 75
Conductivity [IS -cm -1.

7 Ether soluble substance Not more than 0.05 %

8 Water soluble substances Not more than 0.25 %

9 Loss on drying Not more than 7.0 %

10 Sulfated Ash Not more than 0.1 %
111 11 TAMC: acceptance criterion 10 CFU/g
TYMC: acceptance criterion 102 CFU/g
Absence of Escherichia coli /g
Microbial Contamination Absence of Pseudomonas aeruginosa /g
Absence of Staphylococcus aureus /g
Absence of Salmonella /10g

Prepared by Checked by Approve

Sign ‘ '‘
(VV-- 01/12/19 /12 1
Date 01/12/19
Name Puja Bisht Rajesh Suthar Sunil Gupta
Designation Q.C. Executive Q.C. Manager Q. A. Manager