2-((2,3-Dimethylphenyl)(nitroso)amino)benzoic acid
- CAS
- 2114-63-8
- Formula
- C15H14N2O3
- MW
- 270.28 g/mol
ZX-025519
Impurity reference standards
Mefenamic Acid impurity standards
This page brings together 12 Mefenamic Acid related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards.
12reference materials
2pharmacopoeial
1nitrosamines
2isotope labelled
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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial2EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Mefenamic Acid reference materials
1–12 of 12 standards
Questions
Mefenamic Acid impurities, answered
What Mefenamic Acid reference materials are available?
The catalogue currently lists 12 compounds for Mefenamic Acid, including 2 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Mefenamic Acid 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 Mefenamic Acid 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 Mefenamic Acid nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Mefenamic Acid. 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 Mefenamic Acid standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.