Description

cis-Risperidonen-Oxide is a key chemical intermediate and impurity reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of active pharmaceutical ingredients (APIs) and finished drug products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis and quality control of antipsychotic medications.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of process-related impurities and degradation products in Risperidone and related API manufacturing.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for pharmaceutical quality control laboratories.
• Process Chemistry Research: Acts as an intermediate or a marker in studying and optimizing synthetic pathways for benzisoxazole derivatives and other complex heterocycles.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed characterization and control of potential impurities.
• Stability Studies: Employed in forced degradation studies to understand the stability profile of drug substances and to identify likely degradation pathways.
• Academic & Contract Research: Used in academic research and by CROs (Contract Research Organizations) for pharmacological studies and analytical services.

Basic Information

Product Name	cis-Risperidonen-Oxide
CAS No.	1894509-66-0
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	Risperidone N-Oxide (cis-isomer); 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one 1-Oxide (cis); cis-Risperidone Impurity; Risperidone Related Compound; cis-Risperidone N-Oxide; Risperidone EP Impurity; (3Z)-9-Hydroxy-2-methyl-4-(2-(4-(6-fluoro-1,2-benzoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3-one 1-Oxide
EINECS	Contact for details

Quality Control

Our cis-Risperidonen-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, 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 to support your regulatory and research needs.

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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.