Description

Desfluoro Iloperidone (Impurity) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of Iloperidone, an atypical antipsychotic medication. Its primary value lies in enabling precise analytical testing to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient. This compound is essential for research and quality assurance laboratories within the pharmaceutical and fine chemical industries, particularly those focused on neuropsychiatric drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Iloperidone API (Active Pharmaceutical Ingredient) batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC analytical methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Iloperidone meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Process Chemistry Research: Aids in studying and optimizing the synthesis pathway of Iloperidone to minimize the formation of this specific impurity.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Iloperidone drug products.

Basic Information

Product Name	Desfluoro Iloperidone (Impurity)
CAS No.	133454-46-3
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; Iloperidone Desfluoro Impurity; Iloperidone Related Compound; Fanapta Impurity; 4'-(3-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)propoxy)-3'-methoxyacetophenone; Zomaril Impurity
EINECS	Contact for details

Quality Control

Every batch of Desfluoro Iloperidone (Impurity) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistent quality suitable for use as a reference standard. Our quality protocols align with industry best practices for pharmaceutical impurities. A comprehensive Certificate of Analysis (COA) detailing purity, identification, and impurity profile (typically by HPLC) is provided with each shipment to support your regulatory and quality requirements.

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 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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