Description

Iloperidone Impurity 1 is a high-purity reference standard used for the analytical profiling and quality control of the atypical antipsychotic drug, Iloperidone. This compound is critical for ensuring the safety and efficacy of the final pharmaceutical product by enabling the accurate identification and quantification of this specific impurity during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on compliance and impurity characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating test methods.
• Method Development and Validation: Critical for developing and validating precise HPLC, UPLC, or GC methods to monitor Iloperidone and its related substances.
• Quality Control & Batch Release: Used in QA/QC laboratories to establish impurity limits, perform routine batch testing, and ensure product specifications are met.
• Regulatory Submission and Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and levels of this impurity over time under various storage conditions.
• Research and Development: Aids in process chemistry optimization to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Iloperidone Impurity 1
CAS No.	207298-39-3
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 Related Compound A; Iloperidone EP Impurity A; Iloperidone USP Impurity; Fanapt Impurity 1; 4'-Acetyl-2-methoxy-4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]benzophenone; HP 873 Impurity
EINECS	Contact for details

Quality Control

Our Iloperidone Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We adhere to stringent quality management protocols suitable for use in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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