Description

Prucalopride Impurity C is a specified impurity associated with the active pharmaceutical ingredient Prucalopride Succinate. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Prucalopride Impurity C in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) used in impurity profiling.
• Quality Control & Batch Release Testing: Used as a system suitability standard and for comparative analysis to monitor impurity levels against established specifications in active pharmaceutical ingredients (APIs).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to determine drug shelf life.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Prucalopride to minimize the formation of this impurity.

Basic Information

Product Name	Prucalopride Impurity C
CAS No.	1599434-55-5
Molecular Formula	C17H24ClN3O3
Molecular Weight	353.85 g/mol
Synonyms	4-Amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydro-1-benzofuran-7-carboxamide; Prucalopride Related Compound C; (4-Amino-5-chloro-2,3-dihydrobenzofuran-7-yl)-[1-(3-methoxypropyl)piperidin-4-yl]methanone; UNII-8Q3P9Q2F8F; 8Q3P9Q2F8F; Prucalopride EP Impurity C; Prucalopride USP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Prucalopride Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using validated analytical methods such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
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.