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Impurity reference standards

Dabigatran impurity standards

For Dabigatran, the Zemixal catalogue holds 77 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 pharmacopoeial impurity, 4 nitrosamines, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 2 degradation products.

77reference materials
1pharmacopoeial
4nitrosamines
2isotope labelled
Dabigatran structure
Parent API

Dabigatran

CAS
211914-51-1
Formula
C25H25N7O3
MW
471.5 g/mol
Code
ZX-006479

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Nitrosamines4N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Dabigatran reference materials

1–60 of 77 standards
Questions

Dabigatran impurities, answered

What Dabigatran reference materials are available?
The catalogue currently lists 77 compounds for Dabigatran, including 1 pharmacopoeial impurity, 4 nitrosamines, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dabigatran impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Dabigatran impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Do you supply Dabigatran nitrosamine impurities?
Yes. 4 N-nitroso compounds are listed for Dabigatran. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Dabigatran standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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