Name of Product

ISOTRETINOIN

Batch No

20120501

Quantity

20kg

Manufacturing Date

2012.05.08

Expiry Date

2014.05.07

Standard

USP29

Items

Specification

Results

Description

Yellow crystalline powder

complies

Identification  

complies

complies

Organic volatile impurity

complies

complies

Loss on drying

0.5%max

complies

Residue on ignition

0.1%max

complies

Heavy metals

0.002%max

complies

Limit of tretinoin

1.0%max

complies

Assay

98.0-102.0%

99.4%

Conclusion

The product complies with USP29

Chief of QC

Analys