Description

Prucalopride Impurity M is a high-purity reference standard of a specified impurity associated with the active pharmaceutical ingredient Prucalopride. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily utilized by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Prucalopride to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Impurity M in Prucalopride drug substance and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing to monitor and control impurity levels, ensuring adherence to ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of Prucalopride under various environmental conditions.
• Process Chemistry Research: Aids in the optimization of synthetic routes by identifying and characterizing process-related impurities.

Basic Information

Product Name	Prucalopride Impurity M
CAS No.	2181480-01-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prucalopride Related Compound M; Prucalopride EP Impurity M; Prucalopride USP Impurity M; 4-Amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide Impurity M; (R,S)-Prucalopride Impurity M; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity M is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.