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Impurity reference standards

Folic Acid impurity standards

This page brings together 20 Folic 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 6 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

20reference materials
6pharmacopoeial
1nitrosamines
2isotope labelled

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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

Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 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 Folic Acid reference materials

1–20 of 20 standards
Questions

Folic Acid impurities, answered

What Folic Acid reference materials are available?
The catalogue currently lists 20 compounds for Folic Acid, including 6 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards 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 Folic 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 Folic 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 Folic Acid nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Folic 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 Folic Acid 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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