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Impurity reference standards

Pirfenidone impurity standards

This page brings together 18 Pirfenidone related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

18reference materials
2pharmacopoeial
1nitrosamines
1isotope labelled

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Pirfenidone reference materials

1–18 of 18 standards
Questions

Pirfenidone impurities, answered

What Pirfenidone reference materials are available?
The catalogue currently lists 18 compounds for Pirfenidone, including 2 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pirfenidone 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 Pirfenidone 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.
Do you supply Pirfenidone nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Pirfenidone. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Pirfenidone standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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