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Impurity reference standards

Clomipramine impurity standards

16 characterised compounds linked to Clomipramine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 5 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 3 metabolites or hydroxylated analogues and 1 degradation product.

16reference materials
5pharmacopoeial
1nitrosamines
2isotope labelled

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 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 Clomipramine reference materials

1–16 of 16 standards
Questions

Clomipramine impurities, answered

How many Clomipramine impurity standards does Zemixal list?
The catalogue currently lists 16 compounds for Clomipramine, including 5 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 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 Clomipramine 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 Clomipramine 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 Clomipramine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Clomipramine. 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 Clomipramine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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