Description

Perindoprilat Lactam A CAS NO 129970-99-6 is a key pharmaceutical intermediate and impurity reference standard used in the synthesis and quality control of cardiovascular drugs. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs) like Perindopril. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in the development, production, and rigorous testing of antihypertensive medications.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the ACE inhibitor Perindopril and related APIs.
• Reference Standard for Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control the lactam-related impurity (Perindopril Lactam) in Perindopril drug substances and finished products.
• Analytical Research & Method Development: Essential for developing and validating HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Pharmacological Studies: Employed in metabolic and degradation pathway studies to understand drug stability and impurity formation.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing necessary impurity data for health authorities like the FDA and EMA.
• Contract Manufacturing & Research (CRO/CMO): Sourced by service organizations supporting the pharmaceutical industry's development and manufacturing pipelines.

Basic Information

Item	Detail
Product Name	Perindoprilat Lactam A
CAS No.	129970-99-6
Molecular Formula	C19H32N2O5
Molecular Weight	368.47 g/mol
Synonyms	(2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-Carboxybutyl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-Octahydroindole-2-carboxylic Acid; Perindopril Lactam; Perindopril EP Impurity C; Perindopril USP Impurity C; Perindoprilat Lactam; S 9780 Lactam; S-9780 Lactam
EINECS	Contact for details

Quality Control

Our Perindoprilat Lactam A is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to meet the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with USP, EP, ICH, and other relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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