Description

Prucalopride Impurity 24 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient 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 involved in the development, production, and quality assurance of Prucalopride-based medications.

Application

• Primary use as a certified reference standard for the identification and quantification of Prucalopride Impurity 24 in active pharmaceutical ingredient (API) batches.
• Essential component in analytical method development and validation (e.g., HPLC, UPLC) for Prucalopride quality control protocols.
• Critical for regulatory compliance and filing, supporting the documentation of impurity profiles for agencies like the FDA and EMA.
• Used in stability studies to monitor the formation of this specific degradation product over time under various storage conditions.
• Supports pharmaceutical research and development for understanding the degradation pathways and chemistry of Prucalopride.
• Employed by contract research organizations (CROs) and quality control laboratories for third-party testing and certification services.

Basic Information

Item	Detail
Product Name	Prucalopride Impurity 24
CAS No.	1429900-66-2
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 24; Prucalopride Related Compound 24; Benzofuran carboxamide impurity of Prucalopride; UNII-Contact for details; Prucalopride EP Impurity I; Prucalopride USP Impurity; Potential IUPAC name variant: Contact for details
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 24 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile as determined by advanced analytical techniques (HPLC, MS, NMR). We adhere to relevant industry guidelines for impurity standards. COAs are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 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 desiccants.

Specification

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

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