Description

Iloperidone Impurity 2 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Iloperidone. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Iloperidone-related substances in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurities during the manufacturing process.
• Quality Control & Batch Release: Used in routine QC testing to ensure Iloperidone batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to characterize and justify impurity profiles in new drug applications (NDA/ANDA).
• Research and Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize the formation of this impurity.

Basic Information

Product Name	Iloperidone Impurity 2
CAS No.	1309041-89-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iloperidone Related Compound 2; Iloperidone Impurity B; Iloperidone EP Impurity B; Iloperidone USP Impurity; 1-[4-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone (probable structure); Fanapt Impurity 2; 4'-Fluoro-4-piperidinopropiophenone derivative (Iloperidone)
EINECS	Contact for details

Quality Control

Our Iloperidone Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, MS, NMR). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and quality requirements. The material is suitable for use as a pharmaceutical reference standard.

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 (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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