Description

Benazepril Ep Impurity B is a specified impurity used in the quality control and analytical development of the active pharmaceutical ingredient (API) Benazepril. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference standard in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with pharmacopeial monographs (EP, USP).

Application

• Primary use as a pharmacopeial reference standard for Benazepril hydrochloride impurity profiling.
• Critical component in analytical method development and validation (HPLC, UPLC) for pharmaceutical quality control labs.
• Used in stability-indicating studies to monitor degradation pathways of Benazepril API.
• Essential for regulatory compliance and submission, supporting filings with agencies like the FDA and EMA.
• Serves as a system suitability and calibration standard in chromatographic systems.
• Utilized in research and development of generic Benazepril formulations.

Basic Information

Product Name	Benazepril Ep Impurity B
CAS No.	88372-39-8
Molecular Formula	C24H28N2O5
Molecular Weight	424.49 g/mol
Synonyms	(3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid; Benazepril Impurity B; Benazepril Related Compound B; Benazepril EP Impurity B; 1H-1-Benzazepine-1-acetic acid, 2,3,4,5-tetrahydro-3-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-, (3S)-; Benazepril Impurity 2
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured and tested under strict quality management systems. Each batch is characterized and qualified against pharmacopeial standards where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing results from advanced analytical techniques including HPLC, NMR, and MS to confirm identity, purity, and strength. Our quality protocols are designed to meet the exacting requirements of GMP/GLP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccant use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.