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Impurity reference standards

Trazodone impurity standards

28 characterised compounds linked to Trazodone are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 12 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 degradation product.

28reference materials
12pharmacopoeial
1nitrosamines
1isotope labelled

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial12EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Trazodone reference materials

1–28 of 28 standards
Questions

Trazodone impurities, answered

How many Trazodone impurity standards does Zemixal list?
The catalogue currently lists 28 compounds for Trazodone, including 12 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard 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 Trazodone 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 Trazodone 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 Trazodone nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Trazodone. 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 Trazodone 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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