Description

Prucalopride Impurity F is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Prucalopride Succinate. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Prucalopride Succinate API.
• Analytical Method Development and Validation in quality control (QC) laboratories.
• Stability Indicating Studies to monitor impurity formation under various stress conditions.
• Regulatory Compliance and Documentation for drug master files (DMFs) and regulatory submissions (e.g., FDA, EMA).
• Research and Development of Prucalopride synthesis pathways and impurity control strategies.
• Calibration of Analytical Instruments such as High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).

Basic Information

Product Name	Prucalopride Impurity F
CAS No.	1900715-98-1
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 F; Prucalopride Related Compound F; UNII-9W6S5Y1R2F; 9W6S5Y1R2F; 4-Amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydro-1-benzofuran-7-carboxamide Impurity F
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity F is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product 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 (HPLC)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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