Description

Iloperidone Impurity CAS NO 1375651-23-2 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for the quality control and regulatory compliance of the atypical antipsychotic drug, Iloperidone. It serves as a key analytical marker for identifying and quantifying process-related impurities, ensuring the final drug product meets stringent safety and efficacy standards. Pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments rely on this impurity standard to validate their analytical methods and maintain cGMP compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Iloperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products in Iloperidone under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Aids chemists in understanding and optimizing the Iloperidone synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Iloperidone Impurity
CAS No.	1375651-23-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Iloperidone Related Compound; Iloperidone Process Impurity; Iloperidone Degradant; Iloperidone Specified Impurity; 1-[4-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone (probable structure based on CAS); Iloperidone Impurity F (Potential designation); Iloperidone Analog; Iloperidone Intermediate Derivative
EINECS	Contact for details

Quality Control

Every batch of Iloperidone Impurity (CAS 1375651-23-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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