Description

Prucalopride Impurity 31 is a high-purity 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 (API) prucalopride succinate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify, quantify, and monitor this specific impurity in prucalopride succinate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of pharmaceutical batches to confirm they meet stringent pharmacopeial (e.g., USP, EP, ICH) impurity limits.
• Stability Studies: Used to track the formation and level of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Essential for preparing Chemistry, Manufacturing, and Controls (CMC) documentation required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Development: Utilized in R&D laboratories to study the degradation pathways and chemical behavior of prucalopride.

Basic Information

Product Name	Prucalopride Impurity 31
CAS No.	2245785-75-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prucalopride Related Compound 31; Prucalopride Succinate Impurity 31; 4-Amino-5-chloro-N-[1-(3-methoxypropyl)-4-piperidinyl]-2,3-dihydro-7-benzofurancarboxamide Impurity 31; UNII-8V8T5QY5VH; 8V8T5QY5VH; Prucalopride EP Impurity G; Prucalopride Impurity G (EP)
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 31 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing all test results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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