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Impurity reference standards

Venetoclax impurity standards

For Venetoclax, the Zemixal catalogue holds 23 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 metabolite or hydroxylated analogue and 5 degradation products.

23reference materials
1metabolites
5degradants
Venetoclax WS structure
Parent API

Venetoclax WS

CAS
1257044-40-8
Formula
C45H50ClN7O7S
MW
868.4 g/mol
Code
ZX-006899

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

Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants5N-oxides, dimers, lactones and breakdown products

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

All Venetoclax reference materials

1–23 of 23 standards
VNL3
CAS
1235865-75-4
Formula
C15H11FN2O3
MW
286.26 g/mol
ZX-012915
Questions

Venetoclax impurities, answered

What Venetoclax reference materials are available?
The catalogue currently lists 23 compounds for Venetoclax, including 1 metabolite or hydroxylated analogue and 5 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Venetoclax 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 Venetoclax 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.

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