Impurity reference standards
Dabigatran impurities & reference standards
Characterised Dabigatran impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.
123reference materials
12nitrosamine impurities
2isotope-labelled
COAHPLC · NMR · MS on request
Parent API: Dabigatran
211914-51-1 · C25H25N7O3
FAQs — Dabigatran impurities
Which Dabigatran impurities do you supply?
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.
What are Dabigatran impurity standards used for?
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).
Can you synthesise a Dabigatran impurity that is not listed?
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.
Request Dabigatran impurity standards
We reply within one business day with price, pack options, lead time and documentation.