Description

Risperidone n-Oxide CAS NO 832747-55-4 is a key pharmaceutical intermediate and metabolite of the antipsychotic drug risperidone. Its primary value lies in its critical role in drug metabolism studies, impurity profiling, and the development of analytical reference standards for quality control in pharmaceutical manufacturing. This compound is essential for research and development laboratories, quality assurance departments, and manufacturers focused on producing or analyzing risperidone and related active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of risperidone-related impurities in drug substances and finished products.
• Metabolite Research: Used in preclinical and clinical studies to investigate the metabolic pathways, pharmacokinetics, and pharmacodynamics of risperidone.
• Analytical Method Development: Critical for developing and validating high-performance liquid chromatography (HPLC), LC-MS, and other analytical methods for impurity control.
• Process Chemistry & Impurity Synthesis: Employed in the synthesis and characterization of process-related impurities to meet stringent ICH guidelines for pharmaceutical impurities.
• Quality Control & Assurance: Used as a system suitability standard and for routine quality control testing in API and finished dosage form manufacturing.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data on impurity profiles and degradation products.

Basic Information

Product Name	Risperidone n-Oxide
CAS No.	832747-55-4
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	Risperidone N-Oxide; Risperidone N-Oxide Impurity; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one 1-Oxide; Risperidone Impurity N-Oxide; Risperidone Related Compound N-Oxide; Risperidone Metabolite N-Oxide
EINECS	Contact for details

Quality Control

Our Risperidone n-Oxide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to stringent quality management systems, and specifications can be aligned with relevant pharmacopeial standards (e.g., USP, EP) upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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