items |
standard |
result |
appearance |
white crystalline powder |
white crystalline powder |
identification |
a:ir b:rt(hplc) |
conform |
residue on ignition |
0.1% max |
0.03% |
heavy metals |
10 ppm max |
conform |
water |
0.5% max |
0.32% |
specific optical rotation |
+290°~ +300° |
+294° |
impurity |
spirooxiran 1: 0.15% max |
0.03% |
spirooxiran 3: 0.15% max |
0.11% |
|
exemestane related compound c: 0.15% max |
0.03% |
|
exemestane related compound a: 0.15% max |
0.04% |
|
any unspecified impurity:0.1% max |
0.02% |
|
total impurity |
0.5% max |
0.23% |
assay(hplc) |
98.0%-102.0% |
99.8% |