Description

Perindoprilat Lactam B is a key pharmaceutical intermediate and impurity standard used in the synthesis and quality control of cardiovascular active pharmaceutical ingredients (APIs). This compound is critical for ensuring the purity, safety, and efficacy of final drug products, particularly angiotensin-converting enzyme (ACE) inhibitors. It is primarily utilized by pharmaceutical manufacturers, research institutions, and analytical laboratories for process development, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Perindopril and related ACE inhibitor APIs.
• Reference Standard: Used as an analytical standard for the identification and quantification of the Perindoprilat Lactam B impurity in drug substances and finished products.
• Process Development & Validation: Essential for research and development (R&D) to optimize synthetic routes and validate manufacturing processes.
• Quality Control & Assurance (QC/QA): Employed in routine testing to monitor impurity levels and ensure batch-to-batch consistency according to ICH guidelines.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity standards for stability studies and specification setting.
• Academic & Contract Research: Used in pharmacological studies and by contract research organizations (CROs) for method development and specialized testing.

Basic Information

Product Name	Perindoprilat Lactam B
CAS No.	130061-28-8
Molecular Formula	C19H32N2O5
Molecular Weight	368.47 g/mol
Synonyms	(2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)butyl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid; Perindopril Lactam Impurity B; Perindopril EP Impurity B; Perindopril Related Compound B; (S,S,S)-Perindopril Lactam; 1H-Indole-2-carboxylic acid, 1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-, (2S,3aS,7aS)-; Aceon Impurity B.
EINECS	Contact for details

Quality Control

Our Perindoprilat Lactam B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with ICH Q3A, 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); ensure the container is sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.