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Impurity reference standards

Prasugrel impurity standards

For Prasugrel, the Zemixal catalogue holds 39 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 9 pharmacopoeial impurities and 1 nitrosamine.

39reference materials
9pharmacopoeial
1nitrosamines
Prasugrel structure
Parent API

Prasugrel

CAS
150322-43-3
Formula
C20H20FNO3S
MW
373.4 g/mol
Code
ZX-006736

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work

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

All Prasugrel reference materials

1–39 of 39 standards
Questions

Prasugrel impurities, answered

What Prasugrel reference materials are available?
The catalogue currently lists 39 compounds for Prasugrel, including 9 pharmacopoeial impurities and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Prasugrel 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 Prasugrel 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 Prasugrel nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Prasugrel. 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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