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Impurity reference standards

Dronedarone impurity standards

This page brings together 14 Dronedarone related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues and 1 degradation product.

14reference materials
2pharmacopoeial
3metabolites
1degradants

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.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Dronedarone reference materials

1–14 of 14 standards
Questions

Dronedarone impurities, answered

What Dronedarone reference materials are available?
The catalogue currently lists 14 compounds for Dronedarone, including 2 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dronedarone 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 Dronedarone 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.
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