Description

Perindopril Ep Impurity L is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Perindopril. This compound is essential for ensuring the safety and efficacy of cardiovascular medications by enabling the accurate identification and quantification of this specific impurity during manufacturing and stability testing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams involved in the development and production of Perindopril-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Identification & Profiling: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify Perindopril Ep Impurity L in API batches.
• Method Development & Validation: Critical for developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Employed in routine QA/QC testing to ensure Perindopril API and finished drug products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used as a marker to monitor the formation of this specific degradation product under various stress conditions (ICH Q1A).

Basic Information

Product Name	Perindopril Ep Impurity L
CAS No.	111836-22-7
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 EP Impurity L; Perindopril Impurity L; (3S,5aS,9aS,10aS)-5a,6,7,8,9,9a,10,10a-Octahydrocyclopenta[b]pyrrolo[1,2-a]pyrazine-1,3-dicarboxylic acid, 2-[[1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl ester derivative; Perindopril Related Compound L.
EINECS	Contact for details

Quality Control

Our Perindopril Ep Impurity L is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, LC-MS, and NMR. Our quality system is designed to support regulatory requirements, making this standard suitable for use in GMP/GLP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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