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Impurity reference standards

Perindopril impurity standards

27 characterised compounds linked to Perindopril are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 12 pharmacopoeial impurities, 2 nitrosamines and 2 metabolites or hydroxylated analogues.

27reference materials
12pharmacopoeial
2nitrosamines
2metabolites
Perindopril structure
Parent API

Perindopril

CAS
82834-16-0
Formula
C19H32N2O5
MW
368.5 g/mol
Code
ZX-006716

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

Pharmacopoeial12EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Perindopril reference materials

1–27 of 27 standards
Questions

Perindopril impurities, answered

How many Perindopril impurity standards does Zemixal list?
The catalogue currently lists 27 compounds for Perindopril, including 12 pharmacopoeial impurities, 2 nitrosamines and 2 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Perindopril 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 Perindopril 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 Perindopril nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Perindopril. 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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