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Impurity reference standards

Metoprolol impurity standards

This page brings together 40 Metoprolol related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 13 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards and 4 metabolites or hydroxylated analogues.

40reference materials
13pharmacopoeial
1nitrosamines
2isotope labelled
Metoprolol structure
Parent API

Metoprolol

CAS
51384-51-1
Formula
C15H25NO3
MW
267.36 g/mol
Code
ZX-006648

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial13EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Metoprolol reference materials

1–40 of 40 standards
Questions

Metoprolol impurities, answered

What Metoprolol reference materials are available?
The catalogue currently lists 40 compounds for Metoprolol, including 13 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards and 4 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Metoprolol 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 Metoprolol 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 Metoprolol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Metoprolol. 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 Metoprolol 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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