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Impurity reference standards

Apalutamide impurity standards

For Apalutamide, the Zemixal catalogue holds 21 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

21reference materials
1isotope labelled
2metabolites
Apalutamide WS structure
Parent API

Apalutamide WS

CAS
956104-40-8
Formula
C21H15F4N5O2S
MW
477.4 g/mol
Code
ZX-006394

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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

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 Apalutamide reference materials

1–21 of 21 standards
Questions

Apalutamide impurities, answered

What Apalutamide reference materials are available?
The catalogue currently lists 21 compounds for Apalutamide, 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 Apalutamide 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 Apalutamide 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 Apalutamide 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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