Description

7-Hydroxy Risperidone-D4 is a deuterium-labeled analog of the major active metabolite of the antipsychotic drug risperidone. This stable isotope-labeled compound is a critical reference standard and internal standard for precise bioanalytical quantification. It is essential for researchers and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors who require high-purity materials for method development, validation, and pharmacokinetic studies.

Application

• Primary use as a certified reference standard for analytical method development and validation.
• Critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of 7-hydroxyrisperidone in biological matrices.
• Supporting pharmacokinetic and metabolism studies of risperidone in preclinical and clinical research.
• Ensuring accuracy and compliance in bioequivalence testing for generic drug development.
• Use in forensic and clinical toxicology for the definitive identification and measurement of the metabolite.
• Application in quality control (QC) laboratories for the analysis of drug substances and products.

Basic Information

Product Name	7-Hydroxy Risperidone-D4
CAS No.	1215454-04-8
Molecular Formula	C23H23D4FN4O2
Molecular Weight	~ 414.50 g/mol
Synonyms	9-Hydroxyrisperidone-d4; Paliperidone-d4 (related metabolite); 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one-d4; Risperidone Metabolite-d4; 7-OH-Risperidone-d4; Deuterated 7-Hydroxyrisperidone; 7-Hydroxy Risperidone (D4)
EINECS	Contact for details

Quality Control

Our 7-Hydroxy Risperidone-D4 is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (HPLC), chemical purity, isotopic purity (D-content), and residual solvents. We adhere to relevant ICH guidelines for analytical validation. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Chemical Purity	≥ 95.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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