Description

Prucalopride Impurity 32 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Prucalopride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) focused on developing and validating robust analytical methods.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Prucalopride Succinate API batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure API compliance with pharmacopeial standards (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Prucalopride formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Aids in synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Prucalopride Impurity 32
CAS No.	2245785-74-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prucalopride Related Compound 32; Prucalopride Impurity C; Prucalopride Succinate Impurity 32; 4-Amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide Impurity; UNII-6Q8K3S6A2T (component); (R)-Prucalopride Impurity; Process Impurity of Prucalopride
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 32 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm its structure and meet stringent specifications for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines for impurities in new drug substances.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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