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Model No.: USP
ITEMS | SPECIFICATION | RESULTS |
Appearance | White to almost crystalline powder, very hygroscopic | Conforms |
Assay | 99.0%-101.0% | 99.75% |
Ph | 2~3 | 2.5 |
Loss on drying | Not more than 1.0% | 0.3% |
Sulphated ash | Not more than 0.1% | 0.06% |
Identification | IR: Similar to the reference standard HPLC: Similar to the reference standard | Conforms |
Residual solvents (2-propanol) | Not more than 0.5% | 0.20% |
Solubility | Very soluble in water Freely soluble in alcohol (96%) Practically insoluble in 2-propanol | Conforms |
Clarity of solution | (0.1g in 10ml carbon dioxide free water)-clear | Conforms |
2-(2-Hydroxyethyl)pyridine | Not more than 0.2% | Not detected |
2-Vinylpyridine | Not more than 0.2% | 0.06% |
N-Methyl-N,N-bis(2-Pyridin-2-Yl-ethyl) amine | Not more than 0.2% | 0.13% |
Other individual impurity | Not more than 0.1% | Conforms |
Total impurities | Not more than 0.5% | 0.3% |
Conclusion: It conforms to the USP30 STANDARD. |
Product Categories : Pharmaceutical Ingredient > API For Cardiovascular & Blood System Drug