Description

Paliperidone Palmitate-D4 is a deuterated isotopologue of the long-acting atypical antipsychotic paliperidone palmitate, specifically designed for use as an internal standard in analytical chemistry. This high-purity reference material is critical for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments involved in the development and monitoring of paliperidone-based therapeutics.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, isotopically labeled internal standard for the precise quantification of paliperidone palmitate and its metabolites in complex biological matrices like plasma and serum.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and pre-clinical research.
• Bioanalytical Method Development & Validation: Used to develop, optimize, and validate highly sensitive and specific analytical methods, compensating for matrix effects and instrument variability.
• Drug Metabolism Research: Facilitates the identification and quantification of drug metabolites, aiding in the understanding of metabolic pathways.
• Quality Control & Assurance: Supports impurity profiling and assay verification of paliperidone palmitate active pharmaceutical ingredient (API) and finished drug products.
• Regulatory Submissions: Provides the traceable and consistent reference data required for dossiers submitted to regulatory bodies like the FDA and EMA.

Basic Information

Product Name	Paliperidone Palmitate-D4
CAS No.	1794685-21-4
Molecular Formula	C39H53D4FN4O6
Molecular Weight	707.94 g/mol (deuterated form)
Synonyms	9-Hydroxyrisperidone Palmitate-D4; (9S)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate-D4; Paliperidone Palmitate d4; Paliperidone Palmitate Isotope; Invega Sustenna-D4 (labeled analog); R092670-D4; JNJ-37822681-D4
EINECS	Contact for details

Quality Control

Our Paliperidone Palmitate-D4 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment, suitable for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic purity (by MS), and chemical purity. We support compliance with cGMP and ICH guidelines for reference standards used in pharmaceutical development.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

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

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