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 almost white, crystalline powder. Very slightly soluble in water, soluble in acetone, sparingly soluble in 96% ethanol. Dissolves in dilute solutions of alkali hydroxides. It shows polymorphism. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: first identification: - IR spectrum second identification: - UV Spectrum: - TLC - chemical test |
corresponds to reference spectrum the ratio of the absorbance measured at the maximum at 273 ± 2 nm to that measured at 323 ± 2 nm is 5.4 to 5.7 the principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution meet the requirements |
Ph. Eur. |
| Acidity or alkalinity | conforms | Ph. Eur. |
| Related substances: - chlorothiazide (impurity A) - 4-amino-6-chlorobenzene-1,3-disulphonamide (impurity B) - 6-chloro-N-[(6-chloro-7-sulfamoyl-2,3-dihydro-4H-1,2,4-benzothiadiazine-4-yl 1,1-dioxide)methyl]3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide] (impurity C) - unidentified single impurities - sum of impurities |
not more than 0.50% not more than 0.50% not more than 0.50% not more than 0.10% not more than 1.0% |
Ph. Eur. |
| Chlorides | not more than 100 ppm | Ph. Eur. |
| Loss on drying | not more than 0.5% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of hydrochlorothiazide calculated on the dried substance | 98.0% - 102.0% | Ph. Eur. |
| Microbiological purity* - total aerobic microbial count (TAMC) - total combined yeasts/moulds count (TYMC) |
not more than 103 cfu/g not more than 102 cfu/g |
Ph. Eur. 2.6.12 |
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