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Impurity reference standards

Alectinib impurity standards

This page brings together 18 Alectinib related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 1 degradation product.

18reference materials
1isotope labelled
1metabolites
1degradants
Alectinib structure
Parent API

Alectinib

CAS
1256580-46-7
Formula
C30H34N4O2
MW
482.6 g/mol
Code
ZX-006384

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Metabolites1Hydroxy, 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 Alectinib reference materials

1–18 of 18 standards
Questions

Alectinib impurities, answered

What Alectinib reference materials are available?
The catalogue currently lists 18 compounds for Alectinib, including 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue 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 Alectinib 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 Alectinib 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 Alectinib 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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