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COA:
Description | White Crystalline Powder | ||
Results Of Analysis Tests | |||
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 12456810 ≤0.1% Impurity 379 ≤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% | 98.7% | |
Micronized | 30 Mesh≥100% | Pass | |
Conclusion | USP 32(Be Conform With USP 32) |