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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White or almost white powder | Conform |
Assay(HPLC) | >99.0% | 99.68% |
Moisture | ≤0.5% | 0.14% |
Loss on drying | ≤0.5% | 0.05% |
Residue on ignition | ≤0.10% | 0.056% |
Enantiomeric | DR ≤0.10% | 0.0060% |
Diastereomer | DS ≤0.1% | ND |
LR <0.2% | ND | |
Conclusion | Conforms to Factory Standard |
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