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Impurity reference standards

Amiodarone impurity standards

For Amiodarone, the Zemixal catalogue holds 24 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 12 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 1 degradation product.

24reference materials
12pharmacopoeial
1nitrosamines
2isotope labelled

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial12EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, 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 Amiodarone reference materials

1–24 of 24 standards
Questions

Amiodarone impurities, answered

What Amiodarone reference materials are available?
The catalogue currently lists 24 compounds for Amiodarone, including 12 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue 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 Amiodarone 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 Amiodarone 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 Amiodarone nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Amiodarone. 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 Amiodarone 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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