Description

Lurasidone CAS NO 367514-87-2 is a benzisothiazole derivative belonging to the class of atypical antipsychotic agents. It is a critical active pharmaceutical ingredient (API) valued for its specific receptor profile, which targets serotonin 5-HT2A and dopamine D2 receptors. This compound is primarily required by pharmaceutical manufacturers and research institutions for the development and production of medications to treat psychiatric conditions such as schizophrenia and bipolar depression.

Application

• Primary Pharmaceutical Ingredient: Manufacture of finished dosage forms (e.g., tablets) for the treatment of schizophrenia.
• Bipolar Disorder Treatment: Key component in medications approved for depressive episodes associated with bipolar I disorder.
• Clinical Research: Used as a reference standard in pharmacological studies and clinical trials.
• Analytical Development: Serves as a high-purity standard for HPLC, LC-MS, and other analytical method development and validation.
• Formulation R&D: Utilized in pre-formulation and formulation research for new drug delivery systems.
• Generic Drug Production: Essential API for companies developing bioequivalent generic versions of branded lurasidone products.

Basic Information

Product Name	Lurasidone
CAS No.	367514-87-2
Molecular Formula	C28H36N4O2S
Molecular Weight	492.68 g/mol
Synonyms	Lurasidone HCl; SM-13496; (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; Latuda (Brand Name); UNII-22IC88528T
EINECS	Contact for details

Quality Control

Our Lurasidone is manufactured under strict quality management systems. Each batch is tested to meet high-purity pharmaceutical standards, typically exceeding 99.0% by HPLC. We provide comprehensive Certificates of Analysis (COA) detailing results for identity, assay, related substances, residual solvents, and other pharmacopeial tests. Our quality commitment ensures compliance with ICH Q7 guidelines and supports regulatory filings for global markets.

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 low-humidity environment to prevent moisture absorption. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Water (KF)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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