Impurity reference standards
Glimepiride impurity standards
For Glimepiride, the Zemixal catalogue holds 21 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 9 pharmacopoeial impurities, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.
21reference materials
9pharmacopoeial
2isotope labelled
1metabolites
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
Pharmacopoeial9EP, USP, BP or JP named impurities
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 Glimepiride reference materials
1–21 of 21 standards
Questions
Glimepiride impurities, answered
What Glimepiride reference materials are available?
The catalogue currently lists 21 compounds for Glimepiride, including 9 pharmacopoeial impurities, 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 Glimepiride 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 Glimepiride 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 Glimepiride standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.