Product Name:Exemestane, 6-Methyleneandrosta-1,4-diene-3,17-dione
Other Names:Aromasin
Type:Auxiliaries and Other Medicine Chemicals
Specification:99%
Formula: C20H24O2
Mol Wt.:296.41
CAS No.:107868-30-4
EINECS No:634-821-0
Appearance:White crystalline powder
|
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
|
|
