Impurity reference standards
Benazepril impurity standards
Zemixal lists 22 reference materials related to Benazepril, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 8 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards.
22reference materials
8pharmacopoeial
1nitrosamines
2isotope labelled
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
Pharmacopoeial8EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Benazepril reference materials
1–22 of 22 standards
(3S)-3-Amino-1-(tert-butylcarboxymethyl)-2,3,4,5-tetrahydro-1H-benzazepin-2-one
- CAS
- 115406-14-9
- Formula
- C16H22N2O3
- MW
- 290.36 g/mol
ZX-023518
3-Bromo-1,3,4,5-tetrahydro-2H-benzo[b]azepin-2-one
- CAS
- 86499-96-9
- Formula
- C10H10BrNO
- MW
- 240.1 g/mol
ZX-036848
Benazeprilat Benzyl Ester Analogue Trifluoroacetic Acid Salt
- CAS
- 1356578-34-1
- Formula
- C31H31F3N2O7
- MW
- 600.6 g/mol
ZX-042755
Questions
Benazepril impurities, answered
How many Benazepril impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Benazepril, including 8 pharmacopoeial impurities, 1 nitrosamine and 2 isotope-labelled standards. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Benazepril 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 Benazepril 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 Benazepril nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Benazepril. 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 Benazepril standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.