Description

Iloperidone Impurity 31 is a designated impurity reference standard used in the analytical profiling and quality control of the atypical antipsychotic drug, Iloperidone. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Iloperidone Impurity 31 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug's shelf life.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Iloperidone API and formulations comply with stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines on impurities.
• Stability Studies: Acts as a marker to track the formation of this specific impurity under various stress conditions (heat, light, humidity) during forced degradation studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and control strategies.
• Research and Development: Utilized in R&D to understand the degradation pathways and synthesis by-products of Iloperidone.

Basic Information

Product Name	Iloperidone Impurity 31
CAS No.	116218-80-5
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 31; Iloperidone EP Impurity I; Iloperidone USP Related Compound; Fanapt Impurity 31; 4'-Acetyl-2-methoxy-4-[3-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy]acetophenone
EINECS	Contact for details

Quality Control

Our Iloperidone Impurity 31 is manufactured and tested under strict quality management systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container must be sealed immediately after use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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