Description

Perindopril Related Compound E is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of impurities during the development and manufacturing of Perindopril, an important ACE inhibitor medication. It serves as a key analytical tool for ensuring drug safety, efficacy, and regulatory compliance. Pharmaceutical manufacturers, analytical laboratories, and R&D facilities rely on this standard to maintain the highest quality standards in their processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Perindopril active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to ensure Perindopril products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to monitor the formation of degradation products in Perindopril under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurities.
• Chemical Research: Acts as a building block or intermediate for synthetic chemists exploring new derivatives or metabolic pathways of Perindopril.

Basic Information

Product Name	Perindopril Related Compound E
CAS No.	1356837-89-2
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 Impurity E; Perindopril EP Impurity E; Perindopril Related Substance E; (S,S,S,S)-Perindopril; Perindopril Stereoisomer; Perindopril Diastereomer
EINECS	Contact for details

Quality Control

Our Perindopril Related Compound E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral methods for stereochemical identity, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines.

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. The container should be sealed under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (S,S,S,S-isomer)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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