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Impurity reference standards

Naproxen impurity standards

For Naproxen, the Zemixal catalogue holds 35 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 8 pharmacopoeial impurities, 2 isotope-labelled standards and 4 metabolites or hydroxylated analogues.

35reference materials
8pharmacopoeial
2isotope labelled
4metabolites
Naproxen Sodium structure
Parent API

Naproxen Sodium

CAS
26159-34-2
Formula
C14H13NaO3
MW
252.24 g/mol
Code
ZX-004009

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

Pharmacopoeial8EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Naproxen reference materials

1–35 of 35 standards
Questions

Naproxen impurities, answered

What Naproxen reference materials are available?
The catalogue currently lists 35 compounds for Naproxen, including 8 pharmacopoeial impurities, 2 isotope-labelled standards and 4 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 Naproxen 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 Naproxen 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.
Are isotope-labelled Naproxen standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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