Appearance
Identification
Residue on Ignition
Heavy Metals
Water
Specific Optical Rotation
Impurity
Spirooxiran 1
Spirooxiran 2
Exemestane related(Compound C)
Exemestane related(Compound A)
Any unspecified impurity
Total impurity
Assay(HPLC)
Micron
|
White crystalline powder
IR
RT (HPLC)
0.1% Max
10PPM Max
0.5% Max
+290° to +300°
0.15% Max
0.15% Max
0.15% Max
0.15% Max
0.1% Max
0.5% Max
98% to 10.2%
100% Less than 20μm
|
Conform
Conform
Conform
0.04%
Conform
0.03%
+290.86°
Not Detected
Not Detected
Not Detected
Not Detected
0.05%
0.25%
100.02%
Conform
|