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Impurity reference standards

Bicalutamide impurity standards

22 characterised compounds linked to Bicalutamide are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 9 pharmacopoeial impurities, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

22reference materials
9pharmacopoeial
1isotope labelled
2metabolites
Bicalutamide WS structure
Parent API

Bicalutamide WS

CAS
90357-06-5
Formula
C18H14F4N2O4S
MW
430.4 g/mol
Code
ZX-006422

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.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
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 Bicalutamide reference materials

1–22 of 22 standards
Questions

Bicalutamide impurities, answered

How many Bicalutamide impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Bicalutamide, including 9 pharmacopoeial impurities, 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 Bicalutamide 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 Bicalutamide 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 Bicalutamide 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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