Impurity reference standards
Phenytoin impurity standards
Zemixal lists 11 reference materials related to Phenytoin, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues.
11reference materials
4pharmacopoeial
1isotope labelled
4metabolites
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.
By impurity type
Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Phenytoin reference materials
1–11 of 11 standards
Questions
Phenytoin impurities, answered
How many Phenytoin impurity standards does Zemixal list?
The catalogue currently lists 11 compounds for Phenytoin, including 4 pharmacopoeial impurities, 1 isotope-labelled standard and 4 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 Phenytoin 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 Phenytoin 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 Phenytoin standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.