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Macsen Laboratories can source the Best quality Pioglitazone Hydrochloride USP API.
| PRODUCT SPECIFICATIONS | |
|---|---|
| Name of Product | Pioglitazone Hydrochloride USP |
| IUPAC Name | 5-[[4-[2-(5-ethylpyridin-2-yl)ethoxy]phenyl]methyl]-1,3-thiazolidine-2,4-dione;hydrochloride |
| Synonyms | Pioglitazone HCl, Pioglitazone (hydrochloride) |
| CAS No | 112529-15-4 |
| Molecular Formula | C19H21ClN2O3S |
| Molecular Weight | 392.9 |
TECHNICAL SPECIFICATIONS
| SR. No | Criteria | Limit/Specification |
|---|---|---|
| 1 | Appearance | White crystals or crystalline powder |
| 2 | Solubility | Soluble in DMF, slightly soluble in dehydrated alcohol, very slightly soluble in Acetone and Acetonitrile, practically insoluble in water and in Ether. |
| 3 | Identification A)Infrared Absorption B) Chlorides C0 HPLC |
-The Infra Red spectrum of the sample should be concordant with the standard. -It meets the requirements of the test for chloride. -The retention time of the Pioglitazone peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
| 4 | 0rganic impurities A) Hydroxypioglitazone B) Didehydropioglitazone C) N-Alkylpioglitazone D) Any other individual impurity E) Total impurities |
Not more than 0.15 % w/w Not more than 0.15 % w/w Not more than 0.15 % w/w Not more than 0.10 % w/w Not more than 0.5 % w/w |
| 5 | Water determination | Not more than 0.5 % w/w |
| 6 | Residue on ignition | Not more than 0.1 % w/w |
| 7 | Assay (on anhydrous basis) | Not less than 98.0 % w/w and not more than 102.0 % w/w |
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