Description

Prucalopride Impurity 10, also known as Ethyl 4-(4-Amino-5-Chloro-2,3-Dihydrobenzofuran-7-Carboxamido)Piperidine-1-Carboxylate, is a critical pharmaceutical reference standard used to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient (API) prucalopride succinate. This high-purity impurity standard is essential for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and production of prucalopride-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in prucalopride succinate API and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Pharmacopeial Testing: Supports testing to meet the specifications of pharmacopeias such as USP, EP, or JP for prucalopride-related substances.

Basic Information

Product Name	Prucalopride Impurity 10 / Ethyl 4-(4-Amino-5-Chloro-2,3-Dihydrobenzofuran-7-Carboxamido)Piperidine-1-Carboxylate
CAS No.	137211-63-3
Molecular Formula	C17H22ClN3O4
Molecular Weight	367.83 g/mol
Synonyms	Ethyl 4-[(4-Amino-5-chloro-2,3-dihydro-7-benzofuranyl)carbonyl]amino]-1-piperidinecarboxylate; 1-Piperidinecarboxylic acid, 4-[[(4-amino-5-chloro-2,3-dihydro-7-benzofuranyl)carbonyl]amino]-, ethyl ester; Prucalopride Related Compound; Prucalopride Impurity B (may be designated); 4-[[(4-Amino-5-chloro-2,3-dihydro-7-benzofuranyl)carbonyl]amino]-1-piperidinecarboxylic acid ethyl ester; UNII-9J2K91F98A; 9J2K91F98A
EINECS	Contact for details

Quality Control

Our Prucalopride Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra where applicable, is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere or in a desiccator for long-term storage to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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