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Impurity reference standards

Apixaban impurity standards

86 characterised compounds linked to Apixaban are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 pharmacopoeial impurity, 1 nitrosamine, 2 isotope-labelled standards, 9 metabolites or hydroxylated analogues and 4 degradation products.

86reference materials
1pharmacopoeial
1nitrosamines
2isotope labelled
Apixaban structure
Parent API

Apixaban

CAS
503612-47-3
Formula
C25H25N5O4
MW
459.5 g/mol
Code
ZX-006395

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites9Hydroxy, desmethyl and conjugated forms
Degradants4N-oxides, dimers, lactones and breakdown products

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

All Apixaban reference materials

1–60 of 86 standards
Questions

Apixaban impurities, answered

How many Apixaban impurity standards does Zemixal list?
The catalogue currently lists 86 compounds for Apixaban, including 1 pharmacopoeial impurity, 1 nitrosamine, 2 isotope-labelled standards, 9 metabolites or hydroxylated analogues and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Apixaban 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 Apixaban 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 Apixaban nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Apixaban. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Apixaban standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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