Pioglitazone Hydrochloride USP

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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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