Description

BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) is a high-purity chemical reference standard, specifically a process-related impurity of the antihypertensive drug Benazepril. This compound is critical for pharmaceutical research, development, and quality control, enabling accurate identification and quantification of impurities to ensure drug safety and efficacy. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of related substances in Benazepril Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity analysis.
• Stability Indicating Studies: Employed to monitor the formation of degradation products in Benazepril under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure Benazepril batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Synthesis: Acts as an intermediate or a reference compound in chemical synthesis and metabolic pathway studies related to angiotensin-converting enzyme (ACE) inhibitors.

Basic Information

Item	Details
Product Name	BENAZEPRIL RELATED COMPOUND G (15 MG)
CAS No.	103129-58-4
Molecular Formula	C24H28N2O5
Molecular Weight	424.49 g/mol
Synonyms	Ethyl (3S)-3-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetate; Benazepril Impurity G; Benazepril Related Substance G; Benazepril EP Impurity G; (3S)-1-(Carboxymethyl)-3-[[(1S)-1-carboxy-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-1H-1-benzazepin-2-one ethyl ester derivative; 1H-1-Benzazepine-1-acetic acid derivative; Benazepril process impurity.
EINECS	Contact for details

Quality Control

This high-grade reference material is produced and analyzed under strict quality management systems. Each batch undergoes comprehensive testing to confirm identity, purity, and strength. We provide full traceability and Certificates of Analysis (COA) that include data from orthogonal analytical techniques such as HPLC, NMR, and MS. Our quality standards align with the requirements for pharmaceutical reference standards and support compliance with ICH Q3A/B, USP, and EP monographs.

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 in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.