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Impurity reference standards

Fluoxetine impurity standards

For Fluoxetine, the Zemixal catalogue holds 39 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 8 pharmacopoeial impurities, 4 nitrosamines, 3 isotope-labelled standards and 2 metabolites or hydroxylated analogues.

39reference materials
8pharmacopoeial
4nitrosamines
3isotope labelled
Fluoxetine HCl structure
Parent API

Fluoxetine HCl

CAS
59333-67-4
Formula
C17H19ClF3NO
MW
345.8 g/mol
Code
ZX-004043

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

Pharmacopoeial8EP, USP, BP or JP named impurities
Nitrosamines4N-nitroso impurities for ICH M7 work
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Fluoxetine reference materials

1–39 of 39 standards
Questions

Fluoxetine impurities, answered

What Fluoxetine reference materials are available?
The catalogue currently lists 39 compounds for Fluoxetine, including 8 pharmacopoeial impurities, 4 nitrosamines, 3 isotope-labelled standards and 2 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 Fluoxetine 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 Fluoxetine 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 Fluoxetine nitrosamine impurities?
Yes. 4 N-nitroso compounds are listed for Fluoxetine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Fluoxetine standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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