Sertraline hydrochloride
CAS NO.79559-97-0
M.F:C17H18Cl3N
Shelf life:2 years
The detailed specifications are as below:
| Items | Standard |
| Appearance | White powder or crystalline powder |
| Specific optical rotation | +36°～+43° |
| IDENTIFICATION | (1). 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 isomers. |
| (2).UV:The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. | |
| (3). IR:IR spectrum of sample conforms to that of reference standard. | |
| (4). Reaction of chlorides:A solution of it responds to the tests for Chloride. | |
| Appearance of solution | Clear; not more intensely coloured than Y2 or GY2 |
| Related substances | Impurity A:NMT 0.2% |
| Impurity B:NMT 0.2% | |
| Impurity C+D:NMT 0.8% | |
| Impurity F:NMT 0.2% | |
| Any other detectable impurity:NMT 0.1% | |
| Total impurities:NMT 1.5% | |
| Impurity E | NMT 0.2% |
| Isomers | NMT 1.0% |
| Residual solvents | Methanol:NMT 0.3% |
| Ethanol :NMT 0.5% | |
| n-Butanol:NMT 0.5% | |
| Tetrahydrofuran:NMT 0.072% | |
| Ethyl acetate:NMT 0.5% | |
| Toluene:NMT 0.089% | |
| O-dichlorobenzene:NMT 0.036% | |
| N- methyl formamide:NMT 0.088% | |
| Loss on drying | NMT 0.5% |
| Residue on ignition | NMT 0.1% |
| Heavy metals | NMT 0.001% |
| Assay(on dried basis) | NLT 98.5% of C17H17Cl2N·HCl |