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Impurity reference standards

Carvedilol impurity standards

For Carvedilol, the Zemixal catalogue holds 38 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 7 metabolites or hydroxylated analogues and 1 degradation product.

38reference materials
3pharmacopoeial
2nitrosamines
1isotope labelled
Carvedilol structure
Parent API

Carvedilol

CAS
72956-09-3
Formula
C24H26N2O4
MW
406.5 g/mol
Code
ZX-004085

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

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites7Hydroxy, 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 Carvedilol reference materials

1–38 of 38 standards
Questions

Carvedilol impurities, answered

What Carvedilol reference materials are available?
The catalogue currently lists 38 compounds for Carvedilol, including 3 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 7 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 Carvedilol 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 Carvedilol 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 Carvedilol nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Carvedilol. 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 Carvedilol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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