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Impurity reference standards

Ramipril impurity standards

25 characterised compounds linked to Ramipril are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 12 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards and 2 metabolites or hydroxylated analogues.

25reference materials
12pharmacopoeial
1nitrosamines
2isotope labelled
Ramipril structure
Parent API

Ramipril

CAS
87333-19-5
Formula
C23H32N2O5
MW
416.5 g/mol
Code
ZX-004105

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
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Ramipril reference materials

1–25 of 25 standards
Questions

Ramipril impurities, answered

How many Ramipril impurity standards does Zemixal list?
The catalogue currently lists 25 compounds for Ramipril, including 12 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards 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 Ramipril 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 Ramipril 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 Ramipril nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Ramipril. 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 Ramipril standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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