Product Name: megestrol
Synonyms: 17-alpha-hydroxy-6-methylpregna-4,6-diene-3,20-dione;
Molecular Formula: C24H32O4
Molecular Weight: 384.5085
CAS Number: 3562-63-8
EINECS: 222-628-6
Density: 1.15g/cm3
Boiling point: 507.1°C at 760 mmHg
Refractive index: 1.551
TEST ITEMS | STANDARD PRESCRIBE | RESULTS |
Description | White or almost Crystalline Powder | Conform |
Identification | Requirements Standard | Conform |
Specific Rotation | +8.8°~+12.0° | +11° |
Melting Point | 213℃~220℃ | 213℃~216.5℃ |
Water | ≤0.5% | 0.25% |
Residue on Ignition | ≤0.2% | Conform |
Heavy Metals | ≤0.002% | Conform |
Organic volatile impurity | Requirements Standard | Conform |
Assay | 97.0-103.0% | 99% |
Conclusion | The specification conform with USP30 Standard |