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Impurity reference standards

Dabrafenib impurity standards

22 characterised compounds linked to Dabrafenib are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

22reference materials
1isotope labelled
2metabolites
Dabrafenib structure
Parent API

Dabrafenib

CAS
1195765-45-7
Formula
C23H20F3N5O2S2
MW
519.6 g/mol
Code
ZX-006481

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Dabrafenib reference materials

1–22 of 22 standards
Questions

Dabrafenib impurities, answered

How many Dabrafenib impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Dabrafenib, including 1 isotope-labelled standard and 2 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 Dabrafenib 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 Dabrafenib 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.
Are isotope-labelled Dabrafenib 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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