Description

Benazepril Related Compound D is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Benazepril through precise analytical control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material for the identification and quantification of specific impurities in Benazepril API and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine quality control testing in pharmaceutical manufacturing to comply with ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive characterization data for impurity profiles as per FDA, EMA, and ICH requirements.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances over time.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and synthetic pathway investigation for next-generation cardiovascular drugs.

Basic Information

Item	Detail
Product Name	Benazepril Related Compound D
CAS No.	1347874-67-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Benazepril Impurity D; Benazepril Related Substance D; Benazepril EP Impurity D; Benazepril USP Related Compound D; (3S)-3-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid; 1H-1-Benzazepine-1-acetic acid, 2,3,4,5-tetrahydro-3-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-, (3S)-; Benazepril Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Benazepril Related Compound D is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

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

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