Description

Iloperidone Diketo Impurity is a key chemical reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Iloperidone. This compound, designated with CAS NO 170170-50-0, is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling precise identification and quantification of this specific process-related impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams focused on method development, validation, and compliance with stringent pharmacopeial standards (e.g., USP, ICH).

Application

• Pharmaceutical Reference Standard: Primary use as an authenticated impurity standard for calibrating analytical instruments and validating testing methods.
• Method Development & Validation: Crucial for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control impurity levels in Iloperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure every batch of Iloperidone API meets specified impurity limits as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this diketo impurity during Iloperidone production.

Basic Information

Product Name	Iloperidone Diketo Impurity
CAS No.	170170-50-0
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 Keto Impurity; Iloperidone Related Compound K; Iloperidone Impurity K; 4'-(3-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)propoxy)-3'-methoxyacetophenone; Fanapt Diketo Impurity
EINECS	Contact for details

Quality Control

Every batch of our Iloperidone Diketo Impurity is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use as a high-purity reference standard. Identity, purity, and impurity profile are confirmed using advanced techniques including HPLC, GC, MS, and NMR. A detailed Certificate of Analysis (COA) containing batch-specific results, chromatograms, and spectroscopic data is supplied with each shipment to ensure full traceability and compliance with cGMP and ICH guidelines for pharmaceutical impurities.

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 light-sensitive (store away from light). For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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