Adapalene
CAS:106685-40-9
M.F:C28H28O3
M.W:412.52
Appearance:white crystalline powder
Used for APIs
| Appearance | White to off white crystalline powder | White crystalline powder |
| Solubility | Sparingly soluble in tetrahydrofuran, Pratically insoluble in water and ethanol | Complies |
| Appearance of solution | Solution must clear and color NMT BY6 of EP | Complies |
| Heavy metals | 10ppm max | Complies |
| Loss on drying | 0.5% max | 0.1% |
| Sulphate ash | 0.1% max | 0.06% |
| Related substances | Impurity A: 0.3% max Impurity D: 0.2% max Impurity C: 0.15% max Max unknown impurity: 0.1% max Total impurity: 0.5% max | 0.21% 0.11% 0.05% 0.03% 0.43% |
| Assay (on dried basis) | 98.0%～102.0% | 99.4% |