Description

Rac 9-Hydroxyrisperidone-D4 is a deuterated isotopologue of a key metabolite of the antipsychotic drug risperidone, identified by CAS NO 1020719-55-4. This compound serves as a critical internal standard in quantitative bioanalytical methods, ensuring high accuracy and precision in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical research laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and therapeutic drug monitoring.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of 9-hydroxyrisperidone in biological matrices.
• Essential for pharmacokinetic (PK) and bioequivalence studies of risperidone and its related formulations.
• Facilitates therapeutic drug monitoring (TDM) in clinical settings to optimize patient dosage and minimize side effects.
• Supports metabolic pathway research and drug-drug interaction studies involving the cytochrome P450 system, particularly CYP2D6.
• Used in the development and validation of regulatory-compliant analytical methods for Good Laboratory Practice (GLP) and clinical trials.
• Critical material for reference standard and certified reference material (CRM) manufacturers.

Basic Information

Item	Details
Product Name	Rac 9-Hydroxyrisperidone-D4
CAS No.	1020719-55-4
Molecular Formula	C23H23D4FN4O2
Molecular Weight	~ 414.50 g/mol
Synonyms	9-Hydroxyrisperidone-d4; Paliperidone-d4 (impurity/metabolite); Risperidone Metabolite-d4; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one-d4; 9-OH-Risperidone-d4; (±)-9-Hydroxyrisperidone-d4; 9-Hydroxy-risperidone-d4
EINECS	Contact for details

Quality Control

Every batch of Rac 9-Hydroxyrisperidone-D4 is manufactured and tested under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR, HPLC, and MS. A Certificate of Analysis (COA) detailing purity, isotopic enrichment, and identity is provided with each shipment to ensure compliance with your research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity (NMR)	Conforms to structure
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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