Description

(S)-3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid 1,1-dimethylethyl ester, Benazepril HCl is a key pharmaceutical intermediate and the active pharmaceutical ingredient (API) of the angiotensin-converting enzyme (ACE) inhibitor benazepril hydrochloride. This compound is critical for the synthesis of high-purity cardiovascular medications, ensuring therapeutic efficacy and patient safety. It is primarily required by pharmaceutical manufacturers, R&D laboratories, and fine chemical suppliers engaged in the production of antihypertensive and heart failure treatments.

Application

• Active Pharmaceutical Ingredient (API): Direct use in the formulation of benazepril hydrochloride tablets and capsules for the treatment of hypertension and heart failure.
• Pharmaceutical Intermediate: Serves as a crucial synthetic precursor in the multi-step manufacturing process of benazepril and related ACE inhibitors.
• Research & Development: Used in pharmacological studies, metabolic pathway research, and the development of new cardiovascular drug formulations.
• Reference Standard: Employed as a high-purity analytical standard in quality control (QC) and quality assurance (QA) laboratories for HPLC, LC-MS, and NMR method development and validation.
• Process Chemistry: Integral to scale-up and optimization studies for efficient and cost-effective API production under cGMP conditions.

Basic Information

Product Name	(S)-3-Amino-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid 1,1-dimethylethyl ester, Benazepril HCl
CAS No.	103010-60-8
Molecular Formula	C24H28N2O5•HCl
Molecular Weight	460.95 g/mol (as hydrochloride salt)
Synonyms	Benazepril Hydrochloride; Benazepril HCl; (S)-Benazepril Hydrochloride; CGS-14824A; CGS 14824A; Lotensin (Brand Name API); 1H-1-Benzazepine-1-acetic acid, 3-amino-2,3,4,5-tetrahydro-2-oxo-, 1,1-dimethylethyl ester, (S)-, hydrochloride
EINECS	Contact for details

Quality Control

Our Benazepril HCl is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality is assured through a comprehensive battery of analytical tests including HPLC for purity, residual solvent analysis (GC), and identification by IR and NMR spectroscopy. We provide full traceability and Certificates of Analysis (COA) with each batch, documenting compliance with in-house specifications aligned with ICH Q3 and pharmacopeial guidelines. Our commitment to cGMP principles ensures consistency and reliability for critical pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 0.5%
Optical Rotation	[α]20/D: Specific range provided on COA

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