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Impurity reference standards

Ketotifen impurity standards

This page brings together 20 Ketotifen related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 7 pharmacopoeial impurities, 1 nitrosamine and 1 isotope-labelled standard.

20reference materials
7pharmacopoeial
1nitrosamines
1isotope labelled

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards

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

All Ketotifen reference materials

1–20 of 20 standards
Questions

Ketotifen impurities, answered

What Ketotifen reference materials are available?
The catalogue currently lists 20 compounds for Ketotifen, including 7 pharmacopoeial impurities, 1 nitrosamine and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ketotifen 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 Ketotifen 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 Ketotifen nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Ketotifen. 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 Ketotifen 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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