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Impurity reference standards

Sertraline impurity standards

This page brings together 39 Sertraline related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 9 pharmacopoeial impurities, 1 nitrosamine, 3 metabolites or hydroxylated analogues and 1 degradation product.

39reference materials
9pharmacopoeial
1nitrosamines
3metabolites
Sertraline structure
Parent API

Sertraline

CAS
79559-97-0
Formula
C17H18Cl3N
MW
342.7 g/mol
Code
ZX-004060

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites3Hydroxy, 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 Sertraline reference materials

1–39 of 39 standards
Questions

Sertraline impurities, answered

What Sertraline reference materials are available?
The catalogue currently lists 39 compounds for Sertraline, including 9 pharmacopoeial impurities, 1 nitrosamine, 3 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 Sertraline 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 Sertraline 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.
Do you supply Sertraline nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Sertraline. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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