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Impurity reference standards

Ondansetron impurity standards

This page brings together 13 Ondansetron related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 7 pharmacopoeial impurities and 2 metabolites or hydroxylated analogues.

13reference materials
7pharmacopoeial
2metabolites
Ondansetron HCl structure
Parent API

Ondansetron HCl

CAS
103639-04-9
Formula
C18H24ClN3O3
MW
365.9 g/mol
Code
ZX-004203

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. 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

Pharmacopoeial7EP, USP, BP or JP named impurities
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Ondansetron reference materials

1–13 of 13 standards
Questions

Ondansetron impurities, answered

What Ondansetron reference materials are available?
The catalogue currently lists 13 compounds for Ondansetron, including 7 pharmacopoeial impurities and 2 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 Ondansetron 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 Ondansetron 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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