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Impurity reference standards

Erlotinib impurity standards

52 characterised compounds linked to Erlotinib are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 4 pharmacopoeial impurities, 7 metabolites or hydroxylated analogues and 1 degradation product.

52reference materials
4pharmacopoeial
7metabolites
1degradants
Erlotinib structure
Parent API

Erlotinib

CAS
183321-74-6
Formula
C22H23N3O4
MW
393.4 g/mol
Code
ZX-004213

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
Metabolites7Hydroxy, 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 Erlotinib reference materials

1–52 of 52 standards
Questions

Erlotinib impurities, answered

How many Erlotinib impurity standards does Zemixal list?
The catalogue currently lists 52 compounds for Erlotinib, including 4 pharmacopoeial impurities, 7 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 Erlotinib 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 Erlotinib 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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