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107868-30-4原料質(zhì)量指標(biāo)實(shí)測(cè)數(shù)據(jù)展示/質(zhì)檢單COA
Certificate Of Analysis
| Name Of Product | Exemestane |
| Batch No | 20181215 |
| Mfd. Date | 2018/12/15 |
| Shelf Life | 2020/12/14 |
| Quantity | 25kg |
| TEST ITEMS | SPECIFICATION | RESULTS |
| Description | White to pale yellow powder | Conform |
| Identification | Positive | Positive |
| Assay(by HPLC) | 98.0~102.0% | 99.75% |
| Absorbance(E1cm) | 465~495 | 482.5 |
| Melting Point | 191~195°C | 193.5~195.0°C |
| Loss On Drying | 0.5%max | 0.19% |
| Specific Rotation | +288°~ +298° | +290.2° |
| Residue On Ignition | 0.1%max | 0.03% |
| Related Substances | Total:1.5%max | <1.0% |
| Single:0.5%max | <0.4% | |
| Residue Solvents | 0.2%max | 0.1% |
| Heavy Metals | 20PPm max | <10PPm |
| Conclusion | The specification conform with USP36 |
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