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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white power | Conforms |
Impurity I | ≤0.15% | Not detected |
Impurity Ⅱ | ≤0.15% | Not detected |
Impurity Ⅲ | ≤1.0% | Not detected |
Impurity IV | ≤0.5% | 0.42% |
Acylated impurities | ≤0.5% | 0.17% |
Other single impurities | ≤0.5% | 0.05% |
Total miscellaneous | ≤2.0% | 0.68% |
Loss on drying | ≤2.0% | 0.66% |
Assay on dried basis | ≥95% | 99.10% |
Conclusion | Conform to the enterprise standard |
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