Description

Prucalopride Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Prucalopride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Prucalopride Impurity 11 in Prucalopride Succinate API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): A key component in routine batch release testing to ensure API and drug product specifications meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) to establish shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway to minimize the formation of this impurity.

Basic Information

Product Name	Prucalopride Impurity 11
CAS No.	519147-89-8
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 11; Prucalopride Related Compound 11; Prucalopride Succinate Impurity 11; UNII-9K8K3U6U6B; 1-(3-Methoxypropyl)piperidin-4-amine derivative; Benzofuran carboxamide impurity of Prucalopride
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing batch-specific results, ensuring traceability and compliance with current industry standards for reference materials.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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