Mitomycin Related Compounds & Impurities

Mitomycin C is a bioreductive alkylating agent used for bladder, gastric and pancreatic cancers, and topically to prevent surgical fibrosis.

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 Mitomycin reference standards, pharmacopeial and non-pharmacopeial Mitomycin 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 Mitomycin-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

Mitomycins
Mitomycin EP Impurity A
Mitomycin Impurity A (trans-Cinnamamide)
1-Hydroxy-2,7-diamino Mitosene (Mixture cis/trans)
Mitomycin A (Mitomycin EP Impurity B)
Mitomycin EP Impurity C
7-Hydroxy Mitomycin
1-Hydroxy-2,7-diamino Mitosene (Mixture cis/trans)
Mitomycin EP Impurity D
Mitomycin Nitroso Impurity 1
cis-1-Hydroxy-2,7-diamino Mitosene
Mitomycin impurity 1