Isotretinoin cas#4759-48-2 Pharma Grade USP Standard
| Item | Specification | Result | |
| Description | Yellow or orange crystalline powder | Orange crystalline powder | |
| 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% | 0.1% | |
| Residue on ignition | Not more than 0.1% | 0.03% | |
| Heavy metal | Not more than 0.002% | Less than 0.002% | |
| Tretinoin | Not more than 1.0% | 0.2% | |
| Assay | 98.0%-102.0%(Calculated on the dried basis) | 100.1% | |