Description

Perindopril Impurity 23 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Perindopril. This compound is critical for ensuring the purity, safety, and efficacy of cardiovascular medications by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Perindopril Impurity 23 in Perindopril API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Perindopril API batches comply with stringent pharmacopeial limits (e.g., ICH Q3A/B) for specified impurities.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Stability Studies: Acts as a benchmark to track the formation and levels of this specific degradation product under various stress conditions.
• Research & Development: Utilized in pharmaceutical R&D for impurity synthesis studies, route scouting, and process optimization to minimize impurity formation.

Basic Information

Product Name	Perindopril Impurity 23
CAS No.	144540-74-9
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 K; Perindopril Related Compound K; (S,S,S)-Perindopril; Perindopril EP Impurity K; Perindopril USP Related Compound K
EINECS	Contact for details

Quality Control

Every batch of Perindopril Impurity 23 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards and customer specifications. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
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.