Description

Prucalopride Impurity 18 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 analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of gastrointestinal motility drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Prucalopride Impurity 18 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Prucalopride.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Prucalopride Impurity 18
CAS No.	38059-73-3
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; Prucalopride Related Compound 18; 4-Amino-5-chloro-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydro-1-benzofuran-7-carboxamide Impurity; UNII-7Q8K5QVL2P; 7Q8K5QVL2P; Prucalopride EP Impurity I; Prucalopride Impurity (Resolor Impurity)
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 18 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current industry standards for pharmaceutical 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 must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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.