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Items of Analysis | Standard of Analysis | Test Results | |
Appearance | White or almost white crystalline powder | Almost white crystalline powder | |
Identification | A: IR B:TLC C: Positive reaction | Conforms | |
Specific rotation | +99°~+105° | +100.3° | |
Phosphate Ions | ≤1.0% | Conforms | |
Free Betamethasone | ≤1.0% | 0.6% | |
Water | ≤10.0% | 8.1% | |
Residual Solvents | Methanol | ≤3000ppm | 146ppm |
Acetone | ≤5000ppm | 236ppm | |
Assay | 97.0-103.0% | 99.35% | |
Conclusion | Conforms to the requirements of USP 41 |
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