Impurity reference standards
Modafinil impurity standards
For Modafinil, the Zemixal catalogue holds 8 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities and 2 isotope-labelled standards.
8reference materials
3pharmacopoeial
2isotope labelled
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Modafinil reference materials
1–8 of 8 standards
Questions
Modafinil impurities, answered
What Modafinil reference materials are available?
The catalogue currently lists 8 compounds for Modafinil, including 3 pharmacopoeial impurities 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 Modafinil 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 Modafinil 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 Modafinil standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.