ITEM | STANDARD | RESULTS |
Appearance | White, crystalline powder or colorless crystals | Passes |
Identification | Accord With BP2007 | Passes |
Assay | 98.5%~101.0% | 99.97% |
Melting point | 75°C~78°C | 77°C |
Optical rotation | -0.05°~+0.05° | 0.00° |
Heavy metals | ≤ 0.001% | <0.001% |
Related substances | ||
Impurity B | ≤ 0.3% | Passes |
Any other impurity | ≤ 0.3% | Passes |
Total of all impurities apart from impurity B | ≤ 0.7% | Passes |
Impurity F | ≤ 0.1% | Not detected |
Sulphated ash | ≤ 0.1% | 0.02% |
Appearance of solution | Accord With BP2007 | Passes |
Conclusion | COMPLY WITH BP2007 |