Customization: | Available |
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Powder: | Yes |
Customized: | Non-Customized |
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Product name: Orlistat
CAS: 96829-58-2Product | Orlistat | |
batch No. | 202003001 | |
Mfg. date | 20200315 | |
CAS No. | 96829-58-2 | |
Tests | Specifications | Results |
Description | Appearance: white or almost white crystalline powder | White crystalline powder |
Melting point | 42 46°C | 44 45°C |
Identification | HPLC: the retention time of principal peak should comply with its RS. | Conforms |
IR spectrum should, comply with that of its RS. | Conforms | |
Specific rotation | -48° ~-51°. | -50° |
Related substance | Any other Single impurity NMT 1.0% | 0.18% |
Total impurities NMT 2.0% | 0.95% | |
Residual solvents | NMT 3000ppm | Undetectable |
2000ppm | ||
Water | NMT 0.5% | 0.01% |
Residue on ignition | NMT 0.1% | 0.02% |
Heavy metals | NMT 20ppm | Conforms |
Assay | NLT 98.0% (on the anhydrous basis) | 98.9% |
Conclusion: Conforms to the requirements of in house standard. |
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