Pioglitazone Hydrochloride, commonly known as Pioglitazone HCl, is a thiazolidinedione-class active pharmaceutical ingredient used in pharmaceutical formulations for the management of type 2 diabetes mellitus. It acts primarily through activation of peroxisome proliferator-activated receptor gamma (PPAR-γ), influencing insulin-responsive genes involved in glucose and lipid metabolism.
Pioglitazone Hydrochloride has the molecular formula C₁₉H₂₀N₂O₃S·HCl, corresponding to C₁₉H₂₁ClN₂O₃S in molecular-formula notation, and a molecular weight of 392.90 g/mol. Its principal CAS Number is 112529-15-4.
Pioglitazone Hydrochloride is supplied as a pharmaceutical active ingredient for formulation and manufacturing applications. The API is associated with oral antidiabetic formulations and is generally used in the development and manufacture of pioglitazone-containing pharmaceutical products.
The USP monograph defines Pioglitazone Hydrochloride as containing not less than 98.0% and not more than 102.0% of the stated substance, calculated on the anhydrous basis.
Pioglitazone Hydrochloride API is used in pharmaceutical formulation and development for products containing pioglitazone as the active pharmaceutical ingredient. Applications include:
Pioglitazone Hydrochloride is described in the USP-NF monograph, which establishes the identity and assay requirements for the API. The USP specification requires 98.0%–102.0% assay on the anhydrous basis.
The chemical identity and CAS information are also supported by PubChem, which lists CAS 112529-15-4, molecular weight 392.9 g/mol, and the molecular formula C₁₉H₂₁ClN₂O₃S.
Pioglitazone Hydrochloride API intended for pharmaceutical applications should be manufactured and tested under appropriate quality systems and applicable regulatory requirements. Analytical testing can include identification, assay, related substances, water or drying-related controls, residue on ignition and other applicable quality attributes according to the relevant pharmacopoeial or approved specification.
For pharmaceutical manufacturers, the API can be considered for formulation development, commercial production and regulated-market requirements subject to applicable documentation and quality standards.
Pioglitazone Hydrochloride is an established thiazolidinedione API used in pharmaceutical formulations for type 2 diabetes management. With CAS Number 112529-15-4, molecular weight 392.90 g/mol, and a USP assay requirement of 98.0%–102.0% on the anhydrous basis, it is an important pharmaceutical ingredient for formulation and manufacturing applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.3% |
| Water Content | NMT 0.5% |
| Melting Point | Approximately 190–197°C |