Description

Iloperidone Impurity 5 is a designated reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Iloperidone. This high-purity compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods for Iloperidone.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify Iloperidone Impurity 5 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: A critical component in developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure API and finished drug product purity meets specifications (e.g., USP, EP).
• Stability Studies: Used as a marker to monitor the formation of degradation products under various stress conditions (ICH Q1A).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Iloperidone Impurity 5
CAS No.	1487957-15-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(1-Oxido-3,6-dihydro-2H-pyridin-4-yl)-1-(6-fluoro-1,2-benzisoxazol-3-yl)butan-1-one; Iloperidone EP Impurity F; Iloperidone Related Compound F; Iloperidone N-Oxide Impurity; Iloperidone Oxidation Impurity; 1-[4-(1-Oxido-1,2,5,6-tetrahydropyrid-4-yl)butyl]-6-fluoro-1,3-dihydro-2H-benzimidazol-2-one (alternative naming)
EINECS	Contact for details

Quality Control

Every batch of Iloperidone Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material 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)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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