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Impurity reference standards

Promethazine impurity standards

13 characterised compounds linked to Promethazine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 2 degradation products.

13reference materials
2pharmacopoeial
1nitrosamines
1isotope 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. 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
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Promethazine reference materials

1–13 of 13 standards
Questions

Promethazine impurities, answered

How many Promethazine impurity standards does Zemixal list?
The catalogue currently lists 13 compounds for Promethazine, including 2 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Promethazine 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 Promethazine 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 Promethazine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Promethazine. 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 Promethazine 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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