COA ofSertraline:
|
ITEMS |
SPECIFICATION |
RESULTS |
|
CHARACTERISTICS |
A WHITE OR ALMOST WHITE CRYSTALLINE POWDER |
A WHITE CRYSTALLINE POWDER |
|
SPECIFIC OPTICAL ROTATION |
+37.5TO +40.5° |
+39.0° |
|
IDENTIFICATION |
POSITIVE |
CONFORMS |
|
SOLUBILITY OF SOLUTION AND COLOUR |
AS STIPULATED |
CONFORMS |
|
RELATED IMPURITIES |
≤1.0% |
0.1% |
|
LOSS ON DRYING |
≤1.0% |
0.1% |
|
RESIDUE ON IGNITION |
≤0.2% |
0.05% |
|
HEAVY METALS |
≤20UG/G |
<20UG/G |
|
ASSAY |
≥98.5% |
99.5% |