TEST |
STANDARD |
RESULT |
Characteristics Identification Clarity of solution Specific rotation Related substance Total impurities Loss on drying Residue on ignition Heavy metals Assay |
Almost white or light yellow green crystalline powder. Positive -1°～+1° ≤1.0% ≤0.5% ≤1.0% ≤0.5% ≤20ppm ≥98.5%～101.5% |
Conforms Conforms Clear 0° 0.50% 0.39% 0.75% 0.38% <20ppm 99.0% |
Conclusion: Complies with the standard of USP27.
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