Invenza Research

Mitomycin EP Impurity B (CAS No. 4055-39-4), chemically known as [(1aS,8S,8aR,8bS)-6,8a-Dimethoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2′,3′:3,4]pyrrolo[1,2-a]-indol-8-yl]methyl carbamate, is a well-characterized pharmaceutical impurity reference standard associated with Mitomycin. It is widely used by pharmaceutical research laboratories, analytical scientists, contract research organizations (CROs), and quality control laboratories to support impurity identification, chromatographic method development, analytical method validation, and stability studies.

This reference standard plays an important role in ensuring accurate impurity profiling during the development and quality assessment of Mitomycin-based pharmaceutical products. It is suitable for use in analytical techniques such as HPLC, LC-MS, UPLC, and other validated chromatographic methods where reliable impurity characterization is required.

Mitomycin EP Impurity B has the molecular formula C16H19N3O6 and a molecular weight of 349.34 g/mol. It is also known by the chemical name [(1aS,8S,8aR,8bS)-6,8a-Dimethoxy-5-methyl-4,7-dioxo-1,1a,2,4,7,8,8a,8b-octahydroazirino[2′,3′:3,4]pyrrolo[1,2-a]-indol-8-yl]methyl carbamate and is identified by CAS No. 4055-39-4.

Researchers and analytical laboratories utilize this impurity reference standard during pharmaceutical development, quality control testing, method transfer, and regulatory compliance activities. Its use helps support the characterization and monitoring of related substances throughout the product lifecycle.