Description

Risperidone Pyrimidinone-n-Oxide (Risperidone Impurity) is a specified degradation product and process-related impurity of the antipsychotic drug Risperidone. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial guidelines such as ICH Q3A(R2) and Q3B(R2).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Risperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure Risperidone batches meet specified impurity limits for regulatory filings (e.g., ANDA, NDA).
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., photolysis, oxidation) as part of forced degradation and long-term stability testing.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents by providing definitive impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing the Risperidone synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Risperidone Pyrimidinone-n-Oxide (Risperidone Impurity)
CAS No.	1301724-91-3
Molecular Formula	C23H27FN4O3
Molecular Weight	426.49 g/mol
Synonyms	Risperidone N-Oxide Impurity; Risperidone Impurity O; 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 3-oxide; Risperidone Related Compound O; 6-Fluoro-3-[4-[2-(2-methyl-3-oxido-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-3-yl)ethyl]piperidin-1-yl]-1,2-benzisoxazole; Risperidone EP Impurity O; Risperidone USP Related Compound O
EINECS	Contact for details

Quality Control

Our Risperidone Pyrimidinone-n-Oxide is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH, USP, and EP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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