| Item | Specification | Analysis Results | |
| Description | Yellow crystalline powder | Yellow crystalline powder | |
| Identification |
The
IR absorption spectrum should correspond
with reference spectrum
|
Correspond
with reference spectrum
|
|
| Should exhibits maximum absorption at 352nm | Exhibits maximum absorption at 352nm | ||
| Loss on drying | Not more than 0.5% | 0.08% | |
| Residue on ignition | Not more than 0.1% | 0.03% | |
| 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) | 100.0% | |