Description

Prucalopride Intermediate Impurity 3-5 is a high-purity chemical reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Prucalopride. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity during drug development and production, ensuring final product safety and compliance with stringent regulatory guidelines. It is primarily used by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Prucalopride Intermediate Impurity 3-5 in API batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure Prucalopride API meets pharmacopeial specifications (e.g., ICH Q3A/B).
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity over time.
• Process Chemistry Optimization: Helps chemists monitor and minimize the formation of this impurity during the synthesis and purification of Prucalopride.

Basic Information

Product Name	Prucalopride Intermediate Impurity 3-5
CAS No.	2250243-46-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prucalopride Impurity 3-5; Prucalopride Related Compound 3-5; Prucalopride Intermediate 3-5; 2250243-46-8; Prucalopride Process Impurity; Prucalopride Specified Impurity; (S)-4-Amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Prucalopride Intermediate Impurity 3-5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and regulatory standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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