Impurity reference standards
Nicorandil impurity standards
This page brings together 11 Nicorandil related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 4 pharmacopoeial impurities, 1 isotope-labelled standard and 3 degradation products.
11reference materials
4pharmacopoeial
1isotope labelled
3degradants
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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
By impurity type
Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Degradants3N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Nicorandil reference materials
1–11 of 11 standards
Questions
Nicorandil impurities, answered
What Nicorandil reference materials are available?
The catalogue currently lists 11 compounds for Nicorandil, including 4 pharmacopoeial impurities, 1 isotope-labelled standard and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Nicorandil 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 Nicorandil 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 Nicorandil standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.