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Impurity reference standards

Pioglitazone impurity standards

For Pioglitazone, the Zemixal catalogue holds 27 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 pharmacopoeial impurities, 4 metabolites or hydroxylated analogues and 1 degradation product.

27reference materials
6pharmacopoeial
4metabolites
1degradants
Pioglitazone structure
Parent API

Pioglitazone

CAS
111025-46-8
Formula
C19H20N2O3S
MW
356.4 g/mol
Code
ZX-006723

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites4Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Pioglitazone reference materials

1–27 of 27 standards
Questions

Pioglitazone impurities, answered

What Pioglitazone reference materials are available?
The catalogue currently lists 27 compounds for Pioglitazone, including 6 pharmacopoeial impurities, 4 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pioglitazone impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Pioglitazone impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
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