Impurity reference standards
Phenytoin impurities & reference standards
Characterised Phenytoin impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
11reference materials
2isotope-labelled
COAHPLC · NMR · MS on request
FAQs — Phenytoin impurities
Which Phenytoin impurities do you supply?
We list 11 Phenytoin-related reference materials, including process impurities, degradation products, stable-isotope-labelled standards and related compounds. Each is supplied with a COA, and characterisation data (HPLC, 1H-NMR, MS, IR) can be provided on request.
What are Phenytoin impurity standards used for?
They are used for analytical method development and validation, impurity identification and quantification, forced-degradation and stability studies, and to support ANDA, DMF and other regulatory submissions under ICH Q3A/Q3B (and ICH M7 for mutagenic impurities).
Can you synthesise a Phenytoin impurity that is not listed?
Yes. Our custom synthesis service can prepare and characterise unlisted impurities, metabolites and labelled analogues from milligram to gram scale. Share the structure or name and required quantity for a quotation.
Request Phenytoin impurity standards
We reply within one business day with price, pack options, lead time and documentation.