TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White crystals | Conforms |
Identification | Positive | Conforms |
Melting point | 226℃~230℃ | 226.8℃~228.8℃ |
Specific rotation | -123°~-127° | -125° |
Water | ≤5.00% | 3.54% |
Ammonium salts | ≤25ppm | 20ppm |
Arsenic | ≤2ppm | 1ppm |
Benzoic and salicylic acid | No precipitate or violet color appears | Conforms |
Heavy metals | ≤10ppm | 0.5ppm |
P-toluene sulfonamide | ≤10ppm | 4ppm |
O-toluene sulfonamide | ≤10ppm | 6ppm |
Selenium | ≤30ppm | 5ppm |
PH value | ------------- | 6.24 |
Benzoic acid-sulfonamide | ≤25ppm | 10ppm |
Assay | 99.0%~101.0% | 99.32% |
Conclusion: The Product Conforms to USP/BP/EP/FCC. |