Impurity reference standards

Perfenidone impurity standards

This page brings together 3 Perfenidone related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 pharmacopoeial impurity and 1 nitrosamine.

3reference materials

1pharmacopoeial

1nitrosamines

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities

Nitrosamines1N-nitroso impurities for ICH M7 work

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

All Perfenidone reference materials

1–3 of 3 standards

4-Phenylmorpholine

CAS: 92-53-5
Formula: C₁₀H₁₃NO
MW: 163.22 g/mol

ZX-034382

5-Methylpyridin-3-ol

CAS: 42732-49-0
Formula: C₆H₇NO
MW: 109.13 g/mol

ZX-042341

N-Nitroso Pirfenidone EP Impurity A

CAS: 126209-21-0
Formula: C₆H₇N₃O
MW: 137.14 g/mol

ZX-031800

Questions

Perfenidone impurities, answered

What Perfenidone reference materials are available?

The catalogue currently lists 3 compounds for Perfenidone, including 1 pharmacopoeial impurity and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.

What documents come with a Perfenidone 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 Perfenidone 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 Perfenidone nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Perfenidone. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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