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Impurity reference standards

Diclofenac impurity standards

Zemixal lists 47 reference materials related to Diclofenac, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 4 metabolites or hydroxylated analogues and 2 degradation products.

47reference materials
6pharmacopoeial
1nitrosamines
2isotope labelled
Diclofenac Sodium structure
Parent API

Diclofenac Sodium

CAS
15307-79-6
Formula
C14H10Cl2NNaO2
MW
318.1 g/mol
Code
ZX-003999

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Diclofenac reference materials

1–47 of 47 standards
Questions

Diclofenac impurities, answered

How many Diclofenac impurity standards does Zemixal list?
The catalogue currently lists 47 compounds for Diclofenac, including 6 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 4 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Diclofenac 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 Diclofenac 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.
Do you supply Diclofenac nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Diclofenac. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Diclofenac 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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