Description

7-Hydroxy Risperidone is a key pharmacologically active metabolite of the atypical antipsychotic drug risperidone. This compound is of significant importance in pharmaceutical research and development, particularly for metabolic studies, bioanalytical method validation, and as a reference standard. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in drug development, quality control, and regulatory compliance for antipsychotic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of 7-Hydroxy Risperidone and related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolism and activity profile of risperidone.
• Bioanalytical Method Development: Serves as a critical standard for developing and validating HPLC, LC-MS, and other analytical methods in biological matrices.
• Impurity Profiling: Employed in the identification and control of process-related impurities and degradation products during risperidone API manufacturing.
• Clinical Research: Used in studies monitoring drug levels and metabolite ratios in patient plasma for therapeutic drug monitoring (TDM).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.

Basic Information

Product Name	7-Hydroxy Risperidone
CAS No.	147663-04-5
Molecular Formula	C23H27FN4O2
Molecular Weight	410.49 g/mol
Synonyms	9-Hydroxyrisperidone; Risperidone Metabolite; 7-Hydroxy Risperidone; Paliperidone Related Compound; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-7-hydroxy-4-methyl-2H-1,4-benzoxazin-2-one; 7-OH-Risperidone; 9-OH-Risperidone (common misnomer); Risperidone Hydroxy Metabolite
EINECS	Contact for details

Quality Control

Our 7-Hydroxy Risperidone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets high-purity standards suitable for pharmaceutical analysis. Certificates of Analysis (COA) with detailed chromatograms and spectroscopic 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 a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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