raw OA steroids powder
Results Of Analysis Tests | ||
Product name | OA | |
Test Of Analysis | Standard Of Analysis | Results Of Analysis |
Identification(TLC, IR) | HPLC, IR | Positive |
Solubility | Practically insoluble in water; Weakly soluble in chloroform; Slightly soluble in ethanol. | Conforms |
Melting Point | 229-232 °C | 230~232 °C |
Loss On Drying | ≤1.0% | 0.32% |
Residue On Ignition | ≤0.2% | 0.06% |
Related substance | Impurity 1\2\4\5\6\8\10 ≤0.1% Impurity 3\7\9 ≤0.3% Impurity 11 ≤0.5% Individual unknown impurity ≤0.1% Total Impurities ≤1.0% | Conforms Conforms Conforms Conforms 0.91% |
Residual Solvents | Ethanol ≤1365ppm Methanol ≤3000ppm | Conforms |
Assay | 98.0~102.0% | 99.3% |
Micronized | 30 Mesh≥100% | Pass |
Conclusion | USP 32(Be Conform With USP 32) |