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VAQORACHEMICALS
Impurity reference standards

Dronedarone impurities & reference standards

Characterised Dronedarone impurities, degradation products and related compounds for analytical method development, validation, QC release and regulatory filings.

24reference materials
1isotope-labelled
COAHPLC · NMR · MS on request
Reference Standard
Dronedarone chemical structure
Dronedarone
CAS
141626-36-0
Formula
C31H44N2O5S
MW
556.8 g/mol
VQ-036834
Reference Standard
Dronedarone N-Oxide chemical structure
Dronedarone N-Oxide
CAS
1638586-56-7
Formula
C31H44N2O6S
MW
572.8 g/mol
VQ-025410

FAQs — Dronedarone impurities

Which Dronedarone impurities do you supply?

We list 24 Dronedarone-related reference materials, including process impurities, degradation products, 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 Dronedarone 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 Dronedarone 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 Dronedarone impurity standards

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