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Impurity reference standards

Paroxetine impurity standards

This page brings together 43 Paroxetine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 11 pharmacopoeial impurities, 1 nitrosamine and 4 metabolites or hydroxylated analogues.

43reference materials
11pharmacopoeial
1nitrosamines
4metabolites

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

Pharmacopoeial11EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Paroxetine reference materials

1–43 of 43 standards
Questions

Paroxetine impurities, answered

What Paroxetine reference materials are available?
The catalogue currently lists 43 compounds for Paroxetine, including 11 pharmacopoeial impurities, 1 nitrosamine and 4 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Paroxetine 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 Paroxetine 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 Paroxetine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Paroxetine. 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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