Description

Lurasidone Impurity 56 is a high-purity chemical reference standard used in the analytical profiling of the antipsychotic drug Lurasidone Hydrochloride. This compound is critical for pharmaceutical research and development, enabling precise identification, quantification, and control of process-related impurities. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments to ensure drug safety, efficacy, and compliance with stringent international pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Lurasidone API and finished dosage forms.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic techniques for the identification and quantification of specific impurities during stability studies and batch release.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry & Optimization: Aids in the investigation and control of impurity formation during the synthesis, purification, and scale-up of Lurasidone manufacturing processes.
• Stability Indicating Method Development: Employed to develop and validate stability-indicating assays that monitor impurity levels over the drug product's shelf life.
• Academic & Contract Research: Used in universities and CROs for pharmacological studies and advanced research on Lurasidone's degradation pathways.

Basic Information

Item	Details
Product Name	Lurasidone Impurity 56
CAS No.	1841093-19-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound 56; Lurasidone EP Impurity 56; Lurasidone USP Impurity 56; Lurasidone Process Impurity 56; Lurasidone Degradant 56; (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; 1841093-19-3
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity 56 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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