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Impurity reference standards

Saxagliptin impurity standards

Zemixal lists 38 reference materials related to Saxagliptin, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 pharmacopoeial impurities and 6 metabolites or hydroxylated analogues.

38reference materials
2pharmacopoeial
6metabolites
Saxagliptin structure
Parent API

Saxagliptin

CAS
361442-04-8
Formula
C18H25N3O2
MW
315.4 g/mol
Code
ZX-004144

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.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Metabolites6Hydroxy, desmethyl and conjugated forms

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

All Saxagliptin reference materials

1–38 of 38 standards
Questions

Saxagliptin impurities, answered

How many Saxagliptin impurity standards does Zemixal list?
The catalogue currently lists 38 compounds for Saxagliptin, including 2 pharmacopoeial impurities and 6 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 Saxagliptin 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 Saxagliptin 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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