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Impurity reference standards

Siponimod impurity standards

Zemixal lists 27 reference materials related to Siponimod, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 metabolite or hydroxylated analogue.

27reference materials
1metabolites
Siponimod WS structure
Parent API

Siponimod WS

CAS
1230487-00-9
Formula
C29H35F3N2O3
MW
516.6 g/mol
Code
ZX-006820

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

Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Siponimod reference materials

1–27 of 27 standards
Questions

Siponimod impurities, answered

How many Siponimod impurity standards does Zemixal list?
The catalogue currently lists 27 compounds for Siponimod, 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 Siponimod 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 Siponimod 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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