Test Items | Specifications | Results of Analysis |
Appearance | Pale yellow powder | pale yellow powder |
Melting point | 72.0-78.0 | 73.2-74.0 |
Assay | 98%-102% | 99.68% |
loss on drying | NMT0.5% | 0.28% |
Specific rotation | +48.5°~+52.5°(c=0.5in ethanol ) | +50.4° |
Any unspecified impurity | NMT 0.5% | 0.23% |
Heavy metals | NMT 20ppm | conform |
Total specified | NMT2.0% | conform |
Conclusion | The specification comply with USP35 |
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