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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White or almost white crystalline powder | White crystalline powder |
Identification | IR | Conform |
Solution | The solution is clear, and has no more intense color than the Matching Fluid | Conform |
Melting point | 226~231℃ | 227~229℃ |
Light absorption | ≤0.20 | 0.004 |
Specific rotation | -121.5°~ -128.0° | -123.6° |
pH | 3.0~4.5 | 4.2 |
Loss on drying | ≤0.5% | 0.06% |
Residue on ignition | <0.1% | 0.03% |
Any individual impurity | ≤0.5% | <0.5% |
Total impurities | ≤1.0% | <1.0% |
Ethanol | ≤5000ppm | N.D |
Acetone | ≤5000ppm | N.D |
Assay (dry basis) | 98.5%~101.0% | 99.6% |
Particle size | Dv(90)≤800μm | 579μm |
Conclusion | The above mentioned product conforms to current USP |
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