Description

Hydroxy Iloperidone is a key pharmaceutical intermediate and metabolite of the atypical antipsychotic drug Iloperidone. This compound is critical for research and development in neuropharmacology, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It serves as an essential building block for pharmaceutical manufacturers, research institutions, and analytical laboratories focused on central nervous system (CNS) therapeutics. Its precise chemical structure makes it invaluable for ensuring product quality and regulatory compliance in drug development pipelines.

Application

• Pharmaceutical Intermediate: Primary use in the synthesis and manufacturing of the antipsychotic drug Iloperidone and its derivatives.
• Metabolite Reference Standard: Critical for analytical method development and validation in bioanalytical studies for pharmacokinetic and pharmacodynamic research.
• Drug Metabolism Studies: Used in in vitro and in vivo studies to understand the metabolic pathways and bioavailability of Iloperidone.
• Quality Control & Impurity Profiling: Serves as a certified reference material (CRM) for HPLC, LC-MS, and other chromatographic techniques to identify and quantify related substances.
• Research Chemical: Utilized in academic and industrial R&D for exploring new CNS-active compounds and structure-activity relationships (SAR).
• Regulatory Submissions: Provides essential data and materials for regulatory filings (e.g., FDA, EMA) requiring detailed impurity and metabolite information.

Basic Information

Product Name	Hydroxy Iloperidone
CAS No.	133454-55-4
Molecular Formula	C24H27FN2O4
Molecular Weight	426.48 g/mol
Synonyms	1-[4-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone; P88; P-88; Iloperidone Hydroxy Metabolite; Iloperidone Metabolite P88; 4′-Hydroxy Iloperidone; (4′-OH) Iloperidone; Fanapt Metabolite
EINECS	Contact for details

Quality Control

Our Hydroxy Iloperidone is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and IR for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with cGMP guidelines where applicable. Specifications are designed to meet the rigorous demands of pharmaceutical R&D and manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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