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Impurity reference standards

Dapoxetine impurity standards

For Dapoxetine, the Zemixal catalogue holds 15 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 1 degradation product.

15reference materials
1isotope labelled
3metabolites
1degradants

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
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 Dapoxetine reference materials

1–15 of 15 standards
Questions

Dapoxetine impurities, answered

What Dapoxetine reference materials are available?
The catalogue currently lists 15 compounds for Dapoxetine, including 1 isotope-labelled standard, 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 Dapoxetine 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 Dapoxetine 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 Dapoxetine 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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