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VAQORACHEMICALS
Impurity reference standards

Amiodarone impurities & reference standards

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

32reference materials
1nitrosamine impurities
2isotope-labelled
COAHPLC · NMR · MS on request
Reference Standard
2-Butyl Benzofuran chemical structure
2-Butyl Benzofuran
CAS
4265-27-4
Formula
C12H14O
MW
174.24 g/mol
VQ-027136
Reference Standard
Amiodarone D4 chemical structure
Amiodarone D4
CAS
1217169-60-2
Formula
C25H29I2NO3
MW
649.3 g/mol
VQ-043672
Reference Standard
Amiodarone N-Oxide chemical structure
Amiodarone N-Oxide
CAS
318267-30-0
Formula
C25H29I2NO4
MW
661.3 g/mol
VQ-020787

FAQs — Amiodarone impurities

Which Amiodarone impurities do you supply?

We list 32 Amiodarone-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 Amiodarone 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 Amiodarone 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 Amiodarone impurity standards

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