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| Test | Specification |
|---|---|
| Description | White to almost white crystalline powder. |
| Solubility | Soluble in Dimethyl formamide, very slightly soluble in acetonitrile. Practically insoluble in water and in ether |
| Identification | By IR - The IR absorption spectrum of the substance being examined in KBr disc should be concordant with the IR spectrum obtained from Pioglitazone HCL working standard. Chloride Test- Crudy white precipitates should be produced with the chemical test. |
| Appearance of solution (5.0% w/v in methanol) | Solution is clear and not more intensely colored than reference solution BYS7. |
| Loss on drying at 105oC | Not more than 0.50% w/w. |
| Heavy metals | Not more than 20 ppm. |
| Sulphated ash | Not more than 0.1% |
| Related substances (By HPLC) | Single Impurity - Not more than 0.50% Total impurities - Not more than 1.0 % |
| Assay ( by Titrimetry ) | Not less than 98.0 % and not more than 102.0 % w/w calculated on dried basis. |
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Ankleshwar gidc, Ankleshwar, Gujarat 
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