Description

Benazepril Ep Impurity D is a specified impurity and degradation product of the active pharmaceutical ingredient Benazepril hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Benazepril hydrochloride drug substance and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug products comply with stringent pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Benazepril.

Basic Information

Product Name	Benazepril Ep Impurity D
CAS No.	112110-48-2
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 D; Benazepril Related Compound D; Benazepril EP Impurity D; Benazepril Hydrochloride Impurity D; 1H-1-Benzazepine-1-acetic acid, 2,3,4,5-tetrahydro-3-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-, (3S)-; Benazeprilat ethyl ester impurity
EINECS	Contact for details

Quality Control

Our Benazepril Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) detailing all test results, ensuring compliance with ICH Q3A, Q3B, USP, and European Pharmacopoeia (EP) guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C, in a dry environment. This product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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