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Impurity reference standards

Nepafenac impurity standards

This page brings together 8 Nepafenac 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 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

8reference materials
1isotope labelled
1metabolites
Nepafenac structure
Parent API

Nepafenac

CAS
78281-72-8
Formula
C15H14N2O2
MW
254.28 g/mol
Code
ZX-006676

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

Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Nepafenac reference materials

Questions

Nepafenac impurities, answered

What Nepafenac reference materials are available?
The catalogue currently lists 8 compounds for Nepafenac, including 1 isotope-labelled standard and 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 Nepafenac 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 Nepafenac 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 Nepafenac standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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