Description

Iloperidone Impurity 21 is a designated impurity standard used in the pharmaceutical development and quality control of the antipsychotic drug Iloperidone. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of this specific impurity. It is an essential analytical standard for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) focused on active pharmaceutical ingredient (API) manufacturing and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Iloperidone Impurity 21 in API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity detection in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Pharmacopoeial Testing: Supports testing in alignment with pharmacopoeial standards (e.g., USP, EP) where impurity profiles are mandated.

Basic Information

Product Name	Iloperidone Impurity 21
CAS No.	1388072-44-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-[4-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]propoxy]-3-methoxyphenyl]ethanone; Iloperidone Related Compound 21; Iloperidone EP Impurity I; Iloperidone Process Impurity; Fanapt Impurity 21; 4'-{3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]propoxy}-3'-methoxyacetophenone
EINECS	Contact for details

Quality Control

Every batch of Iloperidone Impurity 21 (CAS 1388072-44-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to preserve stability.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Any single unknown impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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