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Impurity reference standards

Oseltamivir impurity standards

This page brings together 29 Oseltamivir 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 8 metabolites or hydroxylated analogues.

29reference materials
7pharmacopoeial
8metabolites
Oseltamivir structure
Parent API

Oseltamivir

CAS
196618-13-0
Formula
C16H28N2O4
MW
312.4 g/mol
Code
ZX-006702

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities
Metabolites8Hydroxy, desmethyl and conjugated forms

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

All Oseltamivir reference materials

1–29 of 29 standards
Questions

Oseltamivir impurities, answered

What Oseltamivir reference materials are available?
The catalogue currently lists 29 compounds for Oseltamivir, including 7 pharmacopoeial impurities and 8 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 Oseltamivir 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 Oseltamivir 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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