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Impurity reference standards

Methotrexate impurity standards

35 characterised compounds linked to Methotrexate are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 10 pharmacopoeial impurities, 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues.

35reference materials
10pharmacopoeial
1isotope labelled
4metabolites
Methotrexate structure
Parent API

Methotrexate

CAS
59-05-2
Formula
C20H22N8O5
MW
454.4 g/mol
Code
ZX-004219

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

Pharmacopoeial10EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Methotrexate reference materials

1–35 of 35 standards
Questions

Methotrexate impurities, answered

How many Methotrexate impurity standards does Zemixal list?
The catalogue currently lists 35 compounds for Methotrexate, including 10 pharmacopoeial impurities, 1 isotope-labelled standard and 4 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 Methotrexate 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 Methotrexate 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.
Are isotope-labelled Methotrexate 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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