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Items of Analysis | Standard of Analysis | Test Results |
Appearance | White to off-white powder | Conforms |
Identification | IR absorption spectra qualitatively comparable to reference standard | Conforms |
HPLC: The retention time of peak consistent with reference standard peak | Conforms | |
Assay( (on dry basis)) | 98.5% -101.5 % | 99.8% |
Related substances | Single impurity ≤0.2% | 0.07% |
Total impurity ≤0.5% | 0.15% | |
Loss on drying | ≤0.5% | 0.18% |
Sulphated ash | ≤0.5% | 0.14% |
Heavy metals | ≤20 ppm | Conforms |
Particle size | D90≤20μm | Conforms |
Conclusion | Conforms to Factory Standard |
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