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Impurity reference standards

Perazine impurity standards

Zemixal lists 18 reference materials related to Perazine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 14 nitrosamines.

18reference materials
14nitrosamines

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Nitrosamines14N-nitroso impurities for ICH M7 work

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

All Perazine reference materials

1–18 of 18 standards
Questions

Perazine impurities, answered

How many Perazine impurity standards does Zemixal list?
The catalogue currently lists 18 compounds for Perazine, including 14 nitrosamines. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Perazine 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 Perazine 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 Perazine nitrosamine impurities?
Yes. 14 N-nitroso compounds are listed for Perazine. 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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