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Impurity reference standards

Mirabegron impurity standards

Zemixal lists 56 reference materials related to Mirabegron, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 4 nitrosamines, 1 isotope-labelled standard and 8 metabolites or hydroxylated analogues.

56reference materials
6pharmacopoeial
4nitrosamines
1isotope labelled
Mirabegron WS structure
Parent API

Mirabegron WS

CAS
223673-61-8
Formula
C21H24N4O2S
MW
396.5 g/mol
Code
ZX-006655

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines4N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites8Hydroxy, desmethyl and conjugated forms

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

All Mirabegron reference materials

1–56 of 56 standards
Questions

Mirabegron impurities, answered

How many Mirabegron impurity standards does Zemixal list?
The catalogue currently lists 56 compounds for Mirabegron, including 6 pharmacopoeial impurities, 4 nitrosamines, 1 isotope-labelled standard and 8 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 Mirabegron 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 Mirabegron 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 Mirabegron nitrosamine impurities?
Yes. 4 N-nitroso compounds are listed for Mirabegron. 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 Mirabegron 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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