NAME OF PRODUCT: LEVAMISOLE HYDROCHLORIDE EP8.0

DATE OF EXPIRY : 4YEARS

CAS NO.: 16595-80-5

Parameter

Specification

Appearance

A white or almost white crystalline powder.

Identification

Specific Optical Rotation

-121° To  -128°

Infrared absorption spectrophotometry

IR spectrophotometry similar to which of Levamisole Hydrochloride CRS

Chlorides

It gives reaction of chlorides

Appearance of solution

Solution S is clear and not more intensely coloured than reference solution Y7.

PH

3.0 to 4.5

Related substance

Impurities A,B,C,D,E: For each impurity, not more than 0.2%

Other individual unspecified impurities: not more than 0.10%

Total of all impurities: not more than 0.3%

Heavy metals

≤20 ppm

Loss on drying

≤0.5%

Sulfated ash

≤0.1%

Assay (calculated on the dried basis)

98.5% to 101.0%

Parameter

In-house Specifications

Microbial Limit

Total Aerobic Microbial Count≤103 cfu/g

Total Yeasts and Molds Count≤102 cfu/g

Escherichia coli should be absent

Conclusion:

The product complies to the standard of EP8.0

Packaging and storage

Protected from light.