Characterised Dabigatran impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
![(E)-3-(2-(((4-(N'-((Hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid chemical structure](/media/structures/UGEWTLXHMYKLCO-UHFFFAOYSA-N.svg)
We list 123 Dabigatran-related reference materials, including process impurities, degradation products, nitrosamine impurities, 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.
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).
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.
We reply within one business day with price, pack options, lead time and documentation.
