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Impurity reference standards

Chlorpromazine impurity standards

This page brings together 29 Chlorpromazine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 5 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 3 degradation products.

29reference materials
5pharmacopoeial
2nitrosamines
1isotope labelled
Chlorpromazine structure
Parent API

Chlorpromazine

CAS
50-53-3
Formula
C17H19ClN2S
MW
318.9 g/mol
Code
ZX-004031

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. 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

Pharmacopoeial5EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products

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

All Chlorpromazine reference materials

1–29 of 29 standards
Questions

Chlorpromazine impurities, answered

What Chlorpromazine reference materials are available?
The catalogue currently lists 29 compounds for Chlorpromazine, including 5 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Chlorpromazine 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 Chlorpromazine 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 Chlorpromazine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Chlorpromazine. 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 Chlorpromazine 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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