Exemestane (trade name Aromasin) is an oral steroidal aromatase inhibitor used in the adjuvant treatment of hormonally-responsive
Test Item | Analysis Specification | Result |
Description | White crystalline power | white crystalline power |
Identification | IR RT(HPLC) | Conforms |
Residue on ignition | ≤0.1% | 0.05% |
Heavy metals | ≤10 ppm | Conforms |
Water | ≤0.5% | 0.05% |
Specific Optical Rotation | +290°~+300° | +296.96° |
Impurity |
|
|
Spirooxiran1 | ≤0.15% | Not Detected |
Spirooxiran2 | ≤0.15% | Not Detected |
Exemestane related compound A | ≤0.15% | Not Detected |
Any unspecified impurity | ≤0.10% | 0.04% |
Total impurity | ≤0.50% | 0.21% |
Assay(HPLC) | 98.0~102.0% | 101.97% |
Micron |
| 100%≤20um |
Conclusion | Conform to USP Standard |
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