Description

3-[2-[4-[4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]benzolyl]piperidin-1-yl]ethyl-2-Methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyriMidin-4-one (Risperidone Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis of Risperidone, an important atypical antipsychotic medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Risperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed as a marker to track degradation pathways and assess the shelf-life of Risperidone formulations under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Supports synthetic chemistry research aimed at understanding and minimizing impurity formation during the Risperidone manufacturing process.

Basic Information

Product Name	3-[2-[4-[4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]benzolyl]piperidin-1-yl]ethyl-2-Methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyriMidin-4-one (Risperidone Impurity)
CAS No.	1329796-66-8
Molecular Formula	C37H39F2N5O2
Molecular Weight	623.74 g/mol
Synonyms	Risperidone Related Compound; Risperidone Impurity; 9-Hydroxyrisperidone Impurity; 3-[2-[4-[4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]benzoyl]-1-piperidinyl]ethyl]-2-methyl-4H,6H,7H,8H,9H-pyrido[1,2-a]pyrimidin-4-one; 1329796-66-8; Risperidone Degradation Product; Risperidone Process Impurity
EINECS	Contact for details

Quality Control

Our Risperidone Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. We provide detailed Certificates of Analysis (COA) that include chromatographic purity, related substance data, and full spectroscopic characterization, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.