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Impurity reference standards

Bisoprolol impurity standards

This page brings together 41 Bisoprolol related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 15 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 5 metabolites or hydroxylated analogues and 1 degradation product.

41reference materials
15pharmacopoeial
1nitrosamines
1isotope labelled
Bisoprolol Fumarate structure
Parent API

Bisoprolol Fumarate

CAS
104344-23-2
Formula
C40H66N2O12
MW
767 g/mol
Code
ZX-004081

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

By impurity type

Pharmacopoeial15EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, 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 Bisoprolol reference materials

1–41 of 41 standards
Questions

Bisoprolol impurities, answered

What Bisoprolol reference materials are available?
The catalogue currently lists 41 compounds for Bisoprolol, including 15 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 5 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 Bisoprolol 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 Bisoprolol 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 Bisoprolol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Bisoprolol. 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 Bisoprolol 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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