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Impurity reference standards

Chlorpheniramine impurity standards

6 characterised compounds linked to Chlorpheniramine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 pharmacopoeial impurities, 1 nitrosamine and 2 metabolites or hydroxylated analogues.

6reference materials
2pharmacopoeial
1nitrosamines
2metabolites

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

Pharmacopoeial2EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Chlorpheniramine reference materials

Questions

Chlorpheniramine impurities, answered

How many Chlorpheniramine impurity standards does Zemixal list?
The catalogue currently lists 6 compounds for Chlorpheniramine, including 2 pharmacopoeial impurities, 1 nitrosamine 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 Chlorpheniramine 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 Chlorpheniramine 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 Chlorpheniramine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Chlorpheniramine. 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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