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Impurity reference standards

Pemetrexed impurity standards

For Pemetrexed, the Zemixal catalogue holds 37 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 4 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.

37reference materials
4pharmacopoeial
1metabolites
Pemetrexed structure
Parent API

Pemetrexed

CAS
137281-23-3
Formula
C20H21N5O6
MW
427.4 g/mol
Code
ZX-006713

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial4EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Pemetrexed reference materials

1–37 of 37 standards
Questions

Pemetrexed impurities, answered

What Pemetrexed reference materials are available?
The catalogue currently lists 37 compounds for Pemetrexed, including 4 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pemetrexed 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 Pemetrexed 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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