Description

Paliperidone n-Oxide is a key pharmaceutical intermediate and metabolite of the antipsychotic agent paliperidone. This compound is of significant importance for research and development in neuropharmacology, particularly in the study of drug metabolism and the development of analytical reference standards. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) for quality control and metabolic profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of paliperidone and its metabolites in analytical methods.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic pathways, pharmacokinetics, and pharmacodynamics of paliperidone.
• Impurity Profiling: Used as a known impurity standard in the quality control and stability testing of paliperidone API to ensure product purity and safety.
• Method Development & Validation: Essential for developing and validating sensitive analytical techniques such as HPLC, LC-MS, and GC-MS in regulatory and research settings.
• Preclinical & Clinical Studies: Employed in toxicology and clinical trial sample analysis to understand drug exposure and metabolite formation.
• Chemical Synthesis Intermediate: Acts as a building block in the synthesis of novel paliperidone derivatives or related chemical entities for drug discovery.

Basic Information

Product Name	Paliperidone n-Oxide
CAS No.	761460-08-6
Molecular Formula	C23H27FN4O4
Molecular Weight	442.48 g/mol
Synonyms	9-Hydroxyrisperidone N-Oxide; Paliperidone N-Oxide; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one 7-Oxide; Risperidone N-Oxide Metabolite; 9-Hydroxy-risperidone N-Oxide; Paliperidone Impurity G (N-Oxide); Paliperidone Related Compound G
EINECS	Contact for details

Quality Control

Our Paliperidone n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for every lot, detailing all test results against established specifications. Our quality commitment ensures the material is suitable for its intended use in research and as a reference standard.

Storage

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

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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