Specification
TEST ITEMS | SPECIFICATION | RESULTS |
Description | White or Almost White Crystalline Powder | white crystalloid powder |
Identification | Positive | Positive |
Assay | 97.0~100.5% | 99.33% |
Specific Rotation | -18° ~ -24° | -22.0° |
Loss On Drying | 1.0%max | 0.13% |
Organic Volatile Impurities | meets the requirements | Conforms |
Ordinary Impurities | 2.0%max | <2.0% |
Residual Solvents | meets the requirements | Conforms |
Residue On Ignition | 0.2%max | 0.05% |
Conclusion | The specification conform with USP30 standard |