Product Name: Medroxyprogesterone Acetate
Synonyms:medroxyprogesterone 17-acetate; hydroxymethylprogesterone acetate; 17alpha-acetoxy-6-alpha-methylpregn-4-ene-3,20-dione; 17a-hydroxy-6a-methyl-4-pregnene-3,20-dione acetate; depo-provera; (6-alpha)-17-(acetyloxy)-6-methylpreg-4-ene-3,20-dione; 17-(acetyloxy)-6-methyl-(6-alpha)-pregn-4-ene-20-dione; 17-(acetyloxy)-6-methyl-20-dion(6alpha)-pregn-4-ene-; 17-acetoxy-6-alpha-methylprogesterone; 17-alpha-hydroxy-6-alpha-methylpregn-4-ene-3,20-dioneacetate; 17-alpha-hydroxy-6-alpha-methyl-progesteronacetate; 17-alpha-hydroxy-6-alpha-methylprogesteroneacetate; 17-hydroxy-6-alpha-methylpregn-4-ene-3,20-dioneacetate; (17-acetyl-6,10,13-trimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-16-yl) acetate
CAS RN.:71-58-9
EINECS: 200-757-9
Molecular Weight: 386.5244
Molecular Formula: C24H34O4
Density: 1.13g/cm3
Melting Point(°C): 206-207°C
Boiling Point(°C): 500.3°C at 760 mmHg
Flash Point(°C): 215°C
refractive_index: 1.53
| ITEMS | SPECIFICATION | RESULTS |
| Character | White or almost white crystalline powder | Almost White crystalline powder |
| Specific optical rotation | +47°to +53° | +48.2° |
| Impurity F | Not more than 0.5% | <0.5% |
| Identification | Complies by IR | Conforms |
| Related substances | Impurity A not more than 0.3% | Undetected |
| Impurity B not more than 0.7% | Undetected | |
| Impurity C not more than 0.2% | Undetected | |
| Impurity D not more than 1.0% | 0.36% | |
| Impurity E not more than 0.2% | Undetected | |
| Impurity G not more than 0.2% | Undetected | |
| Impurity H not more than0.10% | 0.08% | |
| Impurity I not more than 0.2% | Undetected | |
| Unknown impurity not more than 0.10% | 0.05% | |
| Total impurity not more than 1.5% | 0.49% | |
| Loss on drying | Not more than 1.0% | 0.20% |
| Methylene chloride | Not more than 300ppm | 84ppm |
| Methanol | Not more than 2000ppm | 116ppm |
| Assay | Contains 97.0% to 103.0% of C24H34O4 | 99.80% |
| Calculated on dried basis | ||
| Conclusion | The goods conforms to EP6.0 | |