Description

Prucalopride Impurity H is a designated impurity reference standard used in the pharmaceutical development and quality control of Prucalopride Succinate, a selective serotonin 5-HT4 receptor agonist. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing to comply with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Prucalopride Impurity H in Prucalopride API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: A critical component in the QC laboratory for routine analysis to ensure API batches meet specified impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers by providing impurity characterization data.
• Research & Development: Used 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 H
CAS No.	182808-16-8
Molecular Formula	C17H24ClN3O3
Molecular Weight	353.84 g/mol
Synonyms	4-Amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide Impurity H; UNII-9V2I5V3A7B; 1H-Benzimidazole-7-carboxamide, 4-amino-5-chloro-N-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-; Prucalopride Related Compound H; (R,S)-Prucalopride Impurity H
EINECS	Contact for details

Quality Control

Every batch of Prucalopride Impurity H is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results, chromatograms, and traceability information. Our quality standards align with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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