Listing ID #6081311
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| Tests | Specifications | Result |
| Description | White or almost white crystalline powder | White crystalline powder |
| Solubility | diffluent in Ach, slightly soluble in methanol,almost insoluble in chloroform | Complies |
| Identification | ||
| HPLC | Comply with standard | Complies |
| A292/A227 | 2.28~2.42 | 2.36 |
| IR | IR should comply with the reference standard spectrum. | Complies |
| citrate | positive | Complies |
| Acidity | 3.0~5.0 | 3.63 |
| Loss on Drying | ≤1.0% | 0.32% |
| Residue on ignition | ≤0.1% | 0.04% |
| Heavy Metals | ≤20ppm | Complies |
| Relevant Impurity | ≤0.5% | 0.28% |
| Methanol | ≤0.3% | 0.02% |
| Methylene dichloride | ≤0.06% | 0.017% |
| N, N-Dimethyl formamide | ≤0.088% | Not detected |
| Assay | 98.5~101.5% | 99.6% |
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