Description

3-[2-[4-[(Z)-(4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)phenyl](hydroxyimino)methyl]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 development. This compound serves as a specified impurity in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Risperidone, an atypical antipsychotic. It is essential for analytical laboratories, pharmaceutical manufacturers, and regulatory bodies to ensure drug safety, efficacy, and adherence to stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Risperidone API synthesis and purification processes.
• Analytical Method Development and Validation: Serves as a critical standard for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to study the degradation pathways of Risperidone and to establish impurity thresholds in accordance with ICH Q3A and Q3B guidelines.
• Regulatory Submissions and Compliance: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control and meet pharmacopeial monograph requirements.
• Pharmaceutical Research: Used in academic and industrial research to study the metabolism, pharmacokinetics, and toxicological profile of Risperidone-related substances.
• Quality Assurance/Quality Control (QA/QC): Integral for routine batch release testing of Risperidone drug substance and finished dosage forms to ensure product safety.

Basic Information

Item	Details
Product Name	3-[2-[4-[(Z)-(4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)phenyl](hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (Risperidone Impurity)
CAS No.	1346606-24-3
Molecular Formula	C37H40F2N6O2
Molecular Weight	638.75 g/mol
Synonyms	Risperidone Impurity; Risperidone Related Compound; (Z)-Risperidone Impurity; 3-[2-[4-[(Z)-(4-Fluoro-2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)phenyl](hydroxyimino)methyl]-1-piperidinyl]ethyl]-2-methyl-4H,6H,7H,8H,9H-pyrido[1,2-a]pyrimidin-4-one; Risperidone N-Oxide Impurity (isomeric form); Risperidone Degradant; Pharmaceutical Impurity Standard CAS 1346606-24-3
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, NMR, and IR spectroscopy to ensure structural identity and purity. Our quality protocols are designed to support compliance with ICH, USP, and EP guidelines for impurity standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided with every shipment.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.