Pioglitazone Hydrochloride, also known as Pioglitazone HCl, is a thiazolidinedione-class active pharmaceutical ingredient (API) used in pharmaceutical formulations for the management of type 2 diabetes mellitus. It acts as an agonist of peroxisome proliferator-activated receptor gamma (PPARγ), helping improve insulin sensitivity and insulin-dependent glucose utilization.
Pioglitazone Hydrochloride API has the molecular formula C₁₉H₂₀N₂O₃S·HCl and a molecular weight of 392.90 g/mol. Its CAS Number is 112529-15-4. PubChem and USP identify this substance under CAS 112529-15-4.
Pioglitazone Hydrochloride is supplied as a white to almost white crystalline powder. Official drug labeling describes it as an odorless white crystalline powder and reports that it is practically insoluble in water, slightly soluble in anhydrous ethanol and soluble in N,N-dimethylformamide.
The API is used by pharmaceutical manufacturers in the development and production of oral antidiabetic formulations containing pioglitazone. Pioglitazone is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus.
Pioglitazone Hydrochloride API is used as an active ingredient in pharmaceutical formulations intended for type 2 diabetes management. It may be used in the development and manufacture of:
Pioglitazone enhances insulin sensitivity in peripheral tissues and the liver through activation of PPARγ. It is not an insulin secretagogue.
Pioglitazone Hydrochloride has a USP monograph defining an assay range of 98.0% to 102.0%, calculated on the anhydrous basis. USP also specifies residue on ignition NMT 0.1%.
Indian Pharmacopoeia material describes Pioglitazone Hydrochloride as a white or almost white crystalline powder and provides identification by infrared absorption, chromatographic comparison and chloride reaction.
Pioglitazone Hydrochloride API is suitable for pharmaceutical manufacturing where controlled quality, identity, purity and consistency are important. The API can be supplied according to applicable pharmacopoeial and customer-specific requirements, with analytical documentation and quality-control testing as applicable.
For bulk pharmaceutical requirements, Pioglitazone HCl API can be considered for formulation development, commercial pharmaceutical manufacturing and regulated-market applications subject to the applicable quality and regulatory requirements.
Pioglitazone Hydrochloride is an established thiazolidinedione API used in oral antidiabetic formulations. With a CAS Number of 112529-15-4, molecular weight of 392.90 g/mol, and a USP assay requirement of 98.0%–102.0% on the anhydrous basis, it is an important API for pharmaceutical 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% |