Isotretinoin 13-cis-Retinoic acid Isotretinoin, Pharma
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 |
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