Description

cis-Endo-Lurasidone HCl is a high-purity, stereochemically defined pharmaceutical intermediate and reference standard. This compound is critical for research, development, and quality control processes in the synthesis of the active pharmaceutical ingredient Lurasidone, an atypical antipsychotic. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and R&D institutions focused on central nervous system (CNS) therapeutics. The precise control over the cis-endo isomer is essential for ensuring the efficacy and consistency of the final drug product.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of the antipsychotic drug Lurasidone HCl.
• Analytical Reference Standard: Used for method development, validation, and quality control (HPLC, LC-MS) in pharmaceutical analysis.
• Process Research & Development (R&D): Employed in route scouting, optimization, and scale-up studies for API manufacturing.
• Impurity Profiling: Serves as a critical isomer-specific impurity standard to monitor and control the synthesis process.
• Metabolite Studies: Used in pharmacological and toxicological research to understand drug metabolism.
• Regulatory Submissions: Provides essential data and materials for drug master files (DMFs) and regulatory filings.

Basic Information

Product Name	cis-Endo-Lurasidone HCl
CAS No.	1318074-20-2
Molecular Formula	C28H37ClN4O2S
Molecular Weight	529.13 g/mol
Synonyms	(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 hydrochloride; Lurasidone Related Compound H (cis-endo isomer); (3aR,4S,7R,7aS)-N-[(1R,2R)-2-[4-(1,2-Benzothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-4,7-methanoisobenzofuran-1,3-dione hydrochloride; SM-13496 (cis-endo isomer); cis-Endo Isomer of Lurasidone HCl
EINECS	Contact for details

Quality Control

Our cis-Endo-Lurasidone HCl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral HPLC for isomeric purity, to ensure it meets the high standards required for pharmaceutical development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment, supporting compliance with ICH Q3A/B guidelines and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Isomeric Purity (Chiral HPLC)	≥99.0% (cis-endo isomer)
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%

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