Listing ID #4248983
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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% | 0.0032 |
Residue on ignition | ≤0.1% | 0.0004 |
Heavy Metals | ≤20ppm | Complies |
Relevant Impurity | ≤0.5% | 0.0028 |
Methanol | ≤0.3% | 0.0002 |
Methylene dichloride | ≤0.06% | 0.00017 |
N,N-Dimethyl formamide | ≤0.088% | Not detected |
Assay | 98.5~101.5% | 0.996 |