Description

(R)-9-Hydroxy Risperidone is a key chiral metabolite and active pharmaceutical ingredient (API) intermediate. This compound is of critical importance in the development and quality control of enantiomerically pure antipsychotic medications. It is primarily required by pharmaceutical R&D laboratories, analytical reference standard providers, and manufacturers of active pharmaceutical ingredients (APIs) for use as a high-purity reference standard and a synthetic building block.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification, assay, and impurity profiling of Risperidone and its related substances in compliance with pharmacopeial monographs (USP, EP, JP).
• Active Pharmaceutical Ingredient (API) Intermediate: Used in the controlled synthesis of enantiomerically pure antipsychotic drugs, ensuring the final product meets stringent regulatory requirements for chiral purity.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolism, activity, and safety profile of Risperidone.
• Analytical Method Development: Employed by QC/QA laboratories to develop, validate, and calibrate chromatographic methods (HPLC, UPLC) for accurate quantification.
• Impurity Standard: Used to qualify and quantify specified and unspecified impurities during API manufacturing, supporting regulatory filings (e.g., ICH guidelines).
• Clinical Research: Utilized in bioanalytical studies to measure drug and metabolite levels in biological matrices for clinical trial support.

Basic Information

Product Name	(R)-9-Hydroxy Risperidone
CAS No.	130049-85-3
Molecular Formula	C23H27FN4O2
Molecular Weight	410.49 g/mol
Synonyms	(R)-9-Hydroxyrisperidone; (R)-Risperidone Metabolite; Paliperidone Related Compound; (3R,6R,7S,9R)-9-Hydroxy-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4,6,7,8,9,10-hexahydro-1H-pyrido[1,2-a]pyrimidin-1-one; (R)-Paliperidone Impurity; 9-Hydroxy Risperidone (R-enantiomer); Risperidone Metabolite (R)
EINECS	Contact for details

Quality Control

Our (R)-9-Hydroxy Risperidone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and strength, meeting the rigorous standards required for pharmaceutical development. Certificates of Analysis (COA) are provided, detailing results for chiral purity, assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, and Q6A guidelines, and material can be supplied to meet in-house or pharmacopeial (USP/EP) specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0% (anhydrous basis)
Chiral Purity (Chiral HPLC)	≥99.0% (R-enantiomer)
Related Substances (HPLC)	Individual unknown impurity ≤0.10% Total impurities ≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤0.5%
Residue on Ignition	≤0.1%

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