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Test Items | Analysis Standards | Test Results |
Identification | Conform | Conform |
Absorbance | ≤0.30% | Conform |
Specific Rotation | +39°~ +43° | +39.5° |
Chromatography Purity | Conform | Conform |
17α-Isomer | ≤0.50% | 0.40% |
Organic Volatile Impurities | Conform | Conform |
Loss On Drying | ≤0.50% | 0.32% |
Residue On Ignition | ≤0.10% | 0.01% |
Assay | 97~101% | 99.02% |
Conclusion | The specification conforms with USP31 |