Current API product portfolio
HydrochlorothiazideSpecification:
|
|
| chemical name: | 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulphonamide 1,1- dioxide |
| molecular formula: | C7H8ClN3O4S2 |
| structural formula: |  |
| molecular weight: | 297.7 |
| CAS Registery number: | 58-93-5 |
General information: White, or practically white, practically odorless, crystalline powder. Very slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR B. UV |
comparison with reference substance spectrum comparison with reference substance spectrum |
USP |
| Loss on drying | not more than 0.5% | USP |
| Residue on ignition | not more than 0.1% | USP |
| Chloride | not more than 0.035% | USP |
| Selenium | not more than 0.003% | USP |
| Heavy me |
not more than 0.001% | USP |
| Related compounds - benzothiadiazine related compound A - single other impurity - total other impurities excluding benzothiadiazine related compound A |
not more than 1.0% not more than 0.5% not more than 0.90% |
USP |
| Residual solvents: | meets the requirements | USP |
| Content of hydrochlorothiazide calculated on dried substance | 98.0 - 102.0% | USP |
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