Description

Prucalopride Impurity 17 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Prucalopride Succinate. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Prucalopride-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Prucalopride API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate, identify, and quantify Prucalopride Impurity 17 from the main API and other related substances.
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Prucalopride drug substances and products.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Pharmacopoeial Testing: Serves as a reference material for testing against pharmacopoeial monographs (e.g., USP, EP) where impurity limits are specified.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control the formation pathways of this impurity during the API manufacturing process.

Basic Information

Product Name	Prucalopride Impurity 17
CAS No.	932114-06-2
Molecular Formula	C17H24ClN3O3
Molecular Weight	353.84 g/mol
Synonyms	4-Amino-5-chloro-N-[1-(3-methoxypropyl)-4-piperidinyl]-2,3-dihydro-1-benzofuran-7-carboxamide; Prucalopride Related Compound 17; UNII-9J7C1S6K3P; 9J7C1S6K3P; Prucalopride Impurity; 4-Amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide
EINECS	Contact for details

Quality Control

Every batch of Prucalopride Impurity 17 is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. Our quality commitment supports compliance with cGMP and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment 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 standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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