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Impurity reference standards

Iptacopan impurity standards

This page brings together 10 Iptacopan related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 metabolite or hydroxylated analogue.

10reference materials
1metabolites
Iptacopan structure
Parent API

Iptacopan

CAS
1644670-37-0
Formula
C25H30N2O4
MW
422.5 g/mol
Code
ZX-006579

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Iptacopan reference materials

1–10 of 10 standards
Questions

Iptacopan impurities, answered

What Iptacopan reference materials are available?
The catalogue currently lists 10 compounds for Iptacopan, 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 Iptacopan 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 Iptacopan 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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