Description

Iloperidone-D3 is a deuterated isotopologue of the atypical antipsychotic Iloperidone, specifically labeled with three deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical researchers, analytical laboratories, and contract research organizations (CROs) engaged in drug development and regulatory compliance for neuropsychiatric therapeutics.

Application

• Internal Standard for LC-MS/MS: Primary application as a high-purity internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of Iloperidone in biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and non-clinical research.
• Metabolite Identification & Profiling: Aids in the identification and quantification of Iloperidone metabolites, facilitating a deeper understanding of its metabolic pathways.
• Bioequivalence & Therapeutic Drug Monitoring (TDM): Supports robust analytical methods for bioequivalence studies of generic formulations and for monitoring drug concentrations in patient samples.
• Method Development & Validation: Serves as a critical reference material during the development, optimization, and validation of GLP/GCP-compliant analytical methods.
• Drug Impurity & Degradation Studies: Used in stability-indicating methods to differentiate and quantify the parent drug from its potential impurities or degradation products.

Basic Information

Product Name	Iloperidone-D3
CAS No.	1071167-49-1
Molecular Formula	C24H24D3FN2O4
Molecular Weight	429.50 g/mol (approximate)
Synonyms	1-[4-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone-D3; Iloperidone (phenyl-D3); 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]-3'-methoxyacetophenone-D3; Fanapt-D3; Zomaril-D3
EINECS	Contact for details

Quality Control

Every batch of Iloperidone-D3 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to ensure it meets the exacting standards required for use as a certified reference material. A detailed Certificate of Analysis (COA) is supplied with each shipment, reporting key parameters including isotopic purity (D-enrichment), chemical purity (by HPLC), and confirmation of structure (by NMR and MS). Our quality commitment supports compliance with GMP/GLP guidelines for pharmaceutical research.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Meets ICH guidelines

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