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Impurity reference standards

Mebeverine impurity standards

Zemixal lists 17 reference materials related to Mebeverine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.

17reference materials
6pharmacopoeial
1isotope labelled
3metabolites

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

Pharmacopoeial6EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Mebeverine reference materials

1–17 of 17 standards
Questions

Mebeverine impurities, answered

How many Mebeverine impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Mebeverine, including 6 pharmacopoeial impurities, 1 isotope-labelled standard and 3 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 Mebeverine 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 Mebeverine 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 Mebeverine 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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