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Impurity reference standards

Haloperidol impurity standards

This page brings together 45 Haloperidol related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 17 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 4 degradation products.

45reference materials
17pharmacopoeial
1nitrosamines
2isotope labelled

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial17EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants4N-oxides, dimers, lactones and breakdown products

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

All Haloperidol reference materials

1–45 of 45 standards
Questions

Haloperidol impurities, answered

What Haloperidol reference materials are available?
The catalogue currently lists 45 compounds for Haloperidol, including 17 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Haloperidol 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 Haloperidol 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 Haloperidol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Haloperidol. 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 Haloperidol 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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