Testing items | Specifications | Results |
Description | Yellow or greenish-yellow, crystalline powder | Conforms |
Solubility | Practically insoluble in water, sparingly soluble in tetrahydrofuran. Slightly soluble in acetone and in ethanol(96%). Very slightly soluble in cyclohexane | Conforms |
Identification |
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Conforms |
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Conforms | |
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Conforms | |
Loss on drying | ≤0.50% | 0.3% |
Sulfated ash | ≤0.10% | 0.05% |
Heavy metals | ≤20ppm | <20ppm |
Palladium | ≤10ppm | <10ppm |
Related substances | Impurity A ≤0.30% | 0.22% |
Impurity B ≤0.30% | 0.10% | |
Total impurities ≤1.0% | 0.3% | |
Residual solvents | Tetrahydrofuran ≤720ppm | Conforms |
Ethanol ≤5000ppm | Conforms | |
Ethyl Acetate ≤5000ppm | Conforms | |
Assay | 98.0%~102.0% | 99.70% |
Conclusion: The Product Conforms to USP/EP. |