Description

trans-Risperidonen-Oxide is a high-purity chemical intermediate and reference standard of significant importance in pharmaceutical research and development. This compound is critical for analytical method development, impurity profiling, and quality control processes for active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the synthesis and validation of neuroleptic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of related substances in Risperidone and its derivative APIs.
• Impurity Profiling: Essential for characterizing and controlling process-related impurities and degradation products during drug substance manufacturing.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, and GC analytical methods for quality assurance.
• Metabolite Studies: Employed in pharmacological and toxicological research to study metabolic pathways and biotransformation products.
• Process Chemistry Research: Used as a building block or intermediate in route scouting and optimization for novel synthetic pathways.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing well-characterized impurity standards for drug master files.

Basic Information

Product Name	trans-Risperidonen-Oxide
CAS No.	1200448-51-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Risperidone N-Oxide (trans-isomer); trans-Risperidone Impurity; Risperidone Related Compound; 9-Hydroxyrisperidone N-Oxide (trans); 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-2,9-dimethyl-4H-pyrido[1,2-a]pyrimidin-4-one 7-Oxide (trans); Risperidone EP Impurity; Risperidone Oxidative Degradant
EINECS	Contact for details

Quality Control

Our trans-Risperidonen-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided for traceability and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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