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Impurity reference standards

Edoxaban impurity standards

Zemixal lists 71 reference materials related to Edoxaban, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity, 5 metabolites or hydroxylated analogues and 2 degradation products.

71reference materials
1pharmacopoeial
5metabolites
2degradants
Edoxaban structure
Parent API

Edoxaban

CAS
480449-70-5
Formula
C24H30ClN7O4S
MW
548.1 g/mol
Code
ZX-006520

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Metabolites5Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Edoxaban reference materials

1–60 of 71 standards
Questions

Edoxaban impurities, answered

How many Edoxaban impurity standards does Zemixal list?
The catalogue currently lists 71 compounds for Edoxaban, including 1 pharmacopoeial impurity, 5 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Edoxaban 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 Edoxaban 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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