Fosphenytoin Sodium Related Compounds & Impurities

Fosphenytoin Sodium is the water-soluble phosphate ester prodrug of phenytoin, used for status epilepticus and seizure prevention via intravenous or intramuscular administration.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Fosphenytoin Sodium reference standards, pharmacopeial and non-pharmacopeial Fosphenytoin Sodium impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Fosphenytoin Sodium-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Fosphenytoin Sodium
Fosphenytoin
3-Hydroxymethylphenytoin
Fosphenytoin Impurity D
Fosphenytoin monobenzyl ester
Fosphenytoin EP Impurity E
Fosphenytoin Cyclohexyl Impurity
Fosphenytoin Dibenzyl ester impurity
3-(chloromethyl)- 5,5-diphenyl hydantoin

Metabolites

4-Hydroxymephenytoin

Isotope Labelled Compounds

Fosphenytoin D10 Disodium