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Impurity reference standards

Abemaciclib impurity standards

Zemixal lists 25 reference materials related to Abemaciclib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 metabolite or hydroxylated analogue and 2 degradation products.

25reference materials
1metabolites
2degradants
Abemaciclib structure
Parent API

Abemaciclib

CAS
1231929-97-7
Formula
C27H32F2N8
MW
506.6 g/mol
Code
ZX-006367

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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Abemaciclib reference materials

1–25 of 25 standards
Questions

Abemaciclib impurities, answered

How many Abemaciclib impurity standards does Zemixal list?
The catalogue currently lists 25 compounds for Abemaciclib, including 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Abemaciclib 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 Abemaciclib 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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