Description

Prucalopride Impurity 22 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Prucalopride. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable materials for ensuring drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Prucalopride Impurity 22 in drug substance and finished product analysis.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure the sensitivity and specificity of impurity profiling methods.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Process Chemistry Research: Used by process development scientists to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Prucalopride Impurity 22
CAS No.	100192-87-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide Impurity 22; Prucalopride Related Compound 22; UNII-7V3F8J0F5R; 7V3F8J0F5R; 4-Amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydro-1-benzofuran-7-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Prucalopride Impurity 22 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (NMR, MS) to ensure identity, potency, and consistency. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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