Appearance | Yellow crystalline powder |
Specification | USP40 |
Assay | 98-102%,99.8% |
Capacity | 800kg/month |
Packaging | 1kg/bag,10kg/drum |
Item | Specification | Test result |
Description | Yellow crystaler | Yellow crystaler |
Identification | The IR absorption spectrum should correspond with reference spectrum | Complies |
Should exhibits maximum absorption at 352nm | Complies | |
Loss on drying | Not more than 0.5% | 0.1% |
Residue on ignition | Not more than 0.1% | 0.04% |
Heavy metals | Not more than 0.002% | Less than 0.002% |
Limit of isotretinoin | Not more than 5.0% | 0.1% |
Assay | 98.0%~102.0%( Calculated on the dried basis) | 99.7% |
Conclusion |
It complies with all the requirements of USP 40 |