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Impurity reference standards

Tofacitinib impurity standards

Zemixal lists 44 reference materials related to Tofacitinib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 metabolite or hydroxylated analogue and 1 degradation product.

44reference materials
1metabolites
1degradants
Tofacitinib structure
Parent API

Tofacitinib

CAS
477600-75-2
Formula
C16H20N6O
MW
312.37 g/mol
Code
ZX-006868

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
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Tofacitinib reference materials

1–44 of 44 standards
Questions

Tofacitinib impurities, answered

How many Tofacitinib impurity standards does Zemixal list?
The catalogue currently lists 44 compounds for Tofacitinib, including 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 Tofacitinib 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 Tofacitinib 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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