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Impurity reference standards

Fingolimod impurity standards

59 characterised compounds linked to Fingolimod are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 6 pharmacopoeial impurities, 7 metabolites or hydroxylated analogues and 1 degradation product.

59reference materials
6pharmacopoeial
7metabolites
1degradants
Fingolimod structure
Parent API

Fingolimod

CAS
162359-55-9
Formula
C19H33NO2
MW
307.5 g/mol
Code
ZX-006554

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

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites7Hydroxy, 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 Fingolimod reference materials

1–59 of 59 standards
Questions

Fingolimod impurities, answered

How many Fingolimod impurity standards does Zemixal list?
The catalogue currently lists 59 compounds for Fingolimod, including 6 pharmacopoeial impurities, 7 metabolites or hydroxylated analogues 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 Fingolimod 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 Fingolimod 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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