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Impurity reference standards

Agomelatine impurity standards

27 characterised compounds linked to Agomelatine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues and 2 degradation products.

27reference materials
1isotope labelled
6metabolites
2degradants
Agomelatine structure
Parent API

Agomelatine

CAS
138112-76-2
Formula
C15H17NO2
MW
243.3 g/mol
Code
ZX-004019

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. 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
Metabolites6Hydroxy, 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 Agomelatine reference materials

1–27 of 27 standards
Questions

Agomelatine impurities, answered

How many Agomelatine impurity standards does Zemixal list?
The catalogue currently lists 27 compounds for Agomelatine, including 1 isotope-labelled standard, 6 metabolites or hydroxylated analogues 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 Agomelatine 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 Agomelatine 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 Agomelatine 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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