Sertraline hydrochloride cas no 79559-97-0
| Items |
Specification |
Results |
| Appearance |
White powder of crystalline powder |
White crystalline powder |
| Specific optical rotation |
+36°~+43° |
+41.0° |
| IDENTIFICATION |
| HPLC |
The retention time of the major peak of the sample solution corresponds to that of the system suitability solution,as obtained in the test for Enatiomeric. |
Complies |
| UV |
The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. |
Complies |
| IR |
IR spectrum of sample conforms to that of reference standard. |
Complies |
| Reaction of chlorides |
A solution of it responds to the tests for Chloride. |
Complies |
| TESTS |
| Appearance of solution |
Clear;not more intensely coloured than Y2 or GY2 |
Complies |
| Related substances |
|
|
| Impurity A |
NMT 0.2% |
0.01% |
| Impurity B |
NMT 0.2% |
Not found |
| Impurity C+D |
NMT 0.8% |
0.02% |
| Impurity F |
NMT 0.2% |
Not found |
| |
|
0.03%(RRT:0.95) |
| Any other detectable impurity |
NMT 0.1% |
0.03%(RRT:1.2) |
| |
|
0.03%(RRT:1.3) |
| Total impurities |
NMT 1.5% |
0.15% |
| Impurity E |
NMT 0.2% |
Not found |
| Enantiomeric |
NMT 1.0% |
0.02% |
| Residual solvents |
|
|
| Methanol |
NMT 0.3% |
Not found |
| Ethanol |
NMT 0.5% |
0.0636% |
| n-Butanol |
NMT 0.5% |
Not found |
| Tetrahydrofuran |
NMT 0.072% |
Not found |
| Toluene |
NMT 0.089% |
Not found |
| Ethyl acetate |
NMT 0.5% |
Not found |
| Ether |
NMT 0.5% |
0.0007% |
| Chloroben |
NMT 0.036% |
Not found |
| N-methyl formamide |
NMT 0.088% |
Not found |
| Loss on drying |
NMT 0.5% |
0.08% |
| Residue on ignition |
NMT 0.1% |
0.03% |
| Heavy metals |
NMT 0.001% |
Less than 0.001% |
| Assay(on anhydrous basis) |
NLT 98.5% of C17H17Cl2N·HCl |
99.6% |
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