Tests | | Specification | | Results |
| | | | |
Appearance | White powder or white-crystalline powder | white-crystalline powder |
Identification | Positive NMR | complies |
Solubility | Freely soluble in water,almost non-soluble in 95% of Ethanol,aether or chloroform. | complies |
Solution Colority | Solution of 0.7g of substance in 10ml of water has to be colorless | complies |
Clarity of color | <1# (Reference CP2010) | complies |
PH | 3.5-5.0 (Reference CP2010) | 4.00 |
Heavy metals | ≤10 ppm (Reference CP2010) | complies |
Residual Solvent | Ethanol:Not More Than 0.5% | N.D |
Acetic Acid:Not More Than 0.5% | N.D |
Substance Related | ≤5% | | 1.2% |
Count of bacteria | Bacillus < 1000 Entries/ 1g | complies |
Mildew < 100 Entries/ 1g | complies |
Microzyme < 100 Entries/ 1g | complies |
Loss on drying | ≤ 0.5%(Reference CP2010) | 0.30% |
Iron | < 50ppm(Reference CP2010) | Complies |
Assay(Titration) | NLT98% | 99.20% |
Conclusion:. | Comply with the in-house Standard |