ITEM

SPECIFICATIONS

RESULTS

Description

Yellow crystalline powder

Yellow crystalline powder

Identification

The IR absorption spectrum should correspond with reference spectrum

Should exhibits maximum absorption at 354nm

Correspond with reference spectrum

Exhibits maximum absorption at 354nm

Loss on drying

Not more than 0.5%

0.05%

Residue on ignition

Not more than 0.1%

0.02%

Heavy metals

Not more than 0.002%

Less than 0.002%

Organic volatile impurity

Complies

Complies

Tretinoin

Not more than 1.0%

0.28%

Assay

98.0-102.0%

(calculated on the dried basis)

100.1%

Conclusion: It conforms to the requirements of USP34