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Impurity reference standards

Dasatinib impurity standards

For Dasatinib, the Zemixal catalogue holds 41 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 nitrosamines, 6 metabolites or hydroxylated analogues and 2 degradation products.

41reference materials
2nitrosamines
6metabolites
2degradants
Dasatinib structure
Parent API

Dasatinib

CAS
302962-49-8
Formula
C22H26ClN7O2S
MW
488 g/mol
Code
ZX-006486

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

Nitrosamines2N-nitroso impurities for ICH M7 work
Metabolites6Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Dasatinib reference materials

1–41 of 41 standards
Questions

Dasatinib impurities, answered

What Dasatinib reference materials are available?
The catalogue currently lists 41 compounds for Dasatinib, including 2 nitrosamines, 6 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dasatinib 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 Dasatinib 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 Dasatinib nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Dasatinib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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