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Impurity reference standards

Bosutinib impurity standards

For Bosutinib, the Zemixal catalogue holds 26 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 nitrosamine, 1 isotope-labelled standard, 4 metabolites or hydroxylated analogues and 1 degradation product.

26reference materials
1nitrosamines
1isotope labelled
4metabolites
Bosutinib WS structure
Parent API

Bosutinib WS

CAS
380843-75-4
Formula
C26H29Cl2N5O3
MW
530.4 g/mol
Code
ZX-006428

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, 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 Bosutinib reference materials

1–26 of 26 standards
Questions

Bosutinib impurities, answered

What Bosutinib reference materials are available?
The catalogue currently lists 26 compounds for Bosutinib, including 1 nitrosamine, 1 isotope-labelled standard, 4 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 Bosutinib 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 Bosutinib 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 Bosutinib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Bosutinib. 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 Bosutinib 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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