Isotretinoin 4759-48-2 high purity isotretinoin
Item |
Specification |
Test result |
Description |
Orange to yellow crystalline powder |
Correspond |
Identification |
The IR absorption spectrum should correspond with reference spectrum |
Correspond with reference spectrum |
|
Should exhibits maximum absorption at 354nm |
Exhibits maximum absorption at 354nm |
Loss on drying |
Not more than 0.5% |
0.12% |
Residue on ignition |
Not more than 0.1% |
0.03% |
Heavy metals |
Not more than 0.002% |
Less than 0.002% |
Tretinoin |
Not more than 1.0% |
0.1% |
Assay |
98.0%~102.0 %( Calculated on the dried basis) |
100.0% |
Conclusion |
It complies with all the requirements of USP 35 |
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