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Impurity reference standards

Lapatinib impurity standards

Zemixal lists 15 reference materials related to Lapatinib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 metabolite or hydroxylated analogue.

15reference materials
1metabolites

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

Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Lapatinib reference materials

1–15 of 15 standards
Questions

Lapatinib impurities, answered

How many Lapatinib impurity standards does Zemixal list?
The catalogue currently lists 15 compounds for Lapatinib, including 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 Lapatinib 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 Lapatinib 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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