Diroximel Fumarate Related Compounds & Impurities

Diroximel Fumarate is a fumaric acid ester prodrug of monomethyl fumarate with improved gastrointestinal tolerability, used for relapsing multiple sclerosis.

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 Diroximel Fumarate reference standards, pharmacopeial and non-pharmacopeial Diroximel Fumarate 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 Diroximel Fumarate-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

Diroximel Fumarate
Diroximel Fumarate Impurity 1
Diroximel Fumarate Impurity F
Diroximel Fumarate Impurity G
Diroximel Fumarate Impurity H
Diroximel Maleate
(Z)-4-(2-(2,5-dioxopyrrolidin-1-yl)ethoxy)-4-oxobut-2-enoic acid
Diroximel Fumarate Difumarylamide Impurity
Diroximel Impurity 3
bis(2,5-dioxopyrrolidin-1-yl) adipate
Diroximel Impurity 1
Diroximel Fumarate Impurity 2

Isotope Labelled Compounds

Diroximel Fumarate D4