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Impurity reference standards

Rimegepant impurity standards

Zemixal lists 11 reference materials related to Rimegepant, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 nitrosamines.

11reference materials
3nitrosamines

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Nitrosamines3N-nitroso impurities for ICH M7 work

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

All Rimegepant reference materials

1–11 of 11 standards
Questions

Rimegepant impurities, answered

How many Rimegepant impurity standards does Zemixal list?
The catalogue currently lists 11 compounds for Rimegepant, including 3 nitrosamines. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Rimegepant 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 Rimegepant 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 Rimegepant nitrosamine impurities?
Yes. 3 N-nitroso compounds are listed for Rimegepant. 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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