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Test | Specification | Results |
Appearance | White to off white powder | Conforms |
Identification | HPLC conform | Conforms |
Loss on drying | ≤0.3% | 0.25% |
Residue on ignition | ≤0.1% | Conforms |
Ignition residue | ≤0.1% | Conforms |
Chromatographic impurity | Total impurities ≤2.0% Any impurities ≤1.0% | 0.7% 0.1% |
Heavy metals As Pb Cd | ≤10ppm ≤1ppm ≤3ppm ≤1ppm | Conforms Conforms Conforms Conforms |
Total impurities(HPLC) | ≥98% | 99.6% |