Description

Lurasidone Impurity 24 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antipsychotic drug Lurasidone. This high-purity impurity is critical for method validation, stability studies, and ensuring the safety and efficacy of the final drug product. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in API synthesis and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Lurasidone-related impurities.
• Analytical Method Development & Validation: Crucial for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Indicating Studies: Used in forced degradation studies to understand the stability of Lurasidone under various stress conditions (heat, light, pH).
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in the quality control of Lurasidone Active Pharmaceutical Ingredient (API).
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity samples for identification and toxicological assessment.
• Research & Development: Used in synthetic route optimization and impurity profiling during the R&D phase of Lurasidone and its generic versions.

Basic Information

Product Name	Lurasidone Impurity 24
CAS No.	2190680-18-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound 24; Lurasidone EP Impurity I; Lurasidone USP Impurity; Lurasidone Process Impurity; (3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-4,7-methano-2H-isoindole-1,3-dione; UNII-Contact for details; Lurasidone Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to maintain stability and purity.

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 individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.