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items | Specifications | Results |
Appearance | White or off-white crystalline powder | Conforms |
HPLC | The retention time of the major peaking the chromatogram of the sample corresponds to that exhibited by the working standard | Conforms |
Loss on drying | No more than 1.0% | 0.40% |
Residue on Ignition | No more than 0.1% | 0.02% |
Heavy Metals | No more than 20ppm | <10ppm |
Related substances | Total impurities no more than 1.0% | 0.50% |
Single impurity no more than 0.5% | Conforms | |
Residual solvents | Ethyl acetat No more than 0.1% | Conforms |
Ethanol No more than 0.1% | Conforms | |
Purity | No less than 99.0% | 99.50% |