TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | white crystalline powder | Conforms |
Identification | As by reference standard | Conforms |
Solubility | Clear | Conforms |
Acidity or alkalinity | Confirms | Confirms |
Melting point | >225℃ | 229.70℃ |
Loss on drying | ≤0.10% | 0.071% |
Burnt residue | ≤0.10% | 0.032% |
Heavy metals | ≤10ppm | <10ppm |
PH | 4.0~6.0 | 4.53 |
Sulphated ashes | ≤0.10% | 0.057% |
Fungiyeast count | <50CFU/g | Conforms |
Total plate count | <50CFU/g | Conforms |
Optical rotation | -0.10°~+0.10° | Conforms |
Reducing substances | ≤0.10% | 0.030% |
Related substances | ≤0.50% | 0.224% |
Assay | 99.0%~101.0% | 99.17% |
Conclusion: The Product Conforms to EP/USP. |