Drospirenone 67392-87-4 99%
ITEMS |
SPECIFICATION |
RESULTS |
---|---|---|
Appearance |
White or almost white crystalline powder |
Conforms |
Identification |
IR,HPLC |
Conforms |
Melting point |
198-203℃ |
198.4-200.3℃ |
Specific rotation (10mg/ml methanol) |
-186°to -196°
|
-187.2° |
Heavy metals |
≤20ppm |
Conforms |
Water |
≤0.5% |
0.1% |
Sulphated ash |
≤0.1% |
0.06% |
Limit of 1.2-dimethoxyethane Limit of isopropyl ether |
≤0.2% ≤0.1% |
Conforms Conforms |
Related substance(HPLC) |
Single impurity≤0.1% Total inpurities≤0.4% |
0.05% 0.13% |
Assay (anhydrous) |
98.0%-102.0% |
99.8% |
ITEMS |
SPECIFICATION |
RESULTS |
---|---|---|
Appearance |
White or almost white crystalline powder |
Conforms |
Identification |
IR,HPLC |
Conforms |
Melting point |
198-203℃ |
198.4-200.3℃ |
Specific rotation (10mg/ml methanol) |
-186°to -196°
|
-187.2° |
Heavy metals |
≤20ppm |
Conforms |
Water |
≤0.5% |
0.1% |
Sulphated ash |
≤0.1% |
0.06% |
Limit of 1.2-dimethoxyethane Limit of isopropyl ether |
≤0.2% ≤0.1% |
Conforms Conforms |
Related substance(HPLC) |
Single impurity≤0.1% Total inpurities≤0.4% |
0.05% 0.13% |
Assay (anhydrous) |
98.0%-102.0% |
99.8% |
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