Description

Lurasidone Hydrochloride CAS NO 367514-88-3 is a high-purity active pharmaceutical ingredient (API) belonging to the benzisothiazole class of atypical antipsychotics. It is a critical component in the formulation of modern psychiatric medications, offering a favorable safety and efficacy profile. This compound is essential for pharmaceutical manufacturers and research institutions focused on developing and producing treatments for schizophrenia and bipolar depression.

Application

• Primary Pharmaceutical API: The principal active ingredient in the manufacture of oral solid dosage forms (tablets, capsules) for the treatment of schizophrenia in adults and adolescents.
• Bipolar Disorder Treatment: Used in formulations indicated for the treatment of depressive episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate.
• Pharmaceutical Research & Development: Serves as a key reference standard and starting material in preclinical and clinical research for new central nervous system (CNS) therapeutics.
• Generic Drug Manufacturing: A vital raw material for companies producing bioequivalent generic versions of branded lurasidone medications.
• Analytical Standard: Used in quality control laboratories as a high-purity standard for HPLC, LC-MS, and other analytical methods to ensure product identity, assay, and impurity profiles.
• Formulation Development: Employed in studies to develop novel drug delivery systems, such as extended-release formulations, to improve patient compliance.

Basic Information

Product Name	Lurasidone Hydrochloride
CAS No.	367514-88-3
Molecular Formula	C28H37ClN4O2S • HCl
Molecular Weight	529.05 g/mol (Hydrochloride salt)
Synonyms	SM-13496; Lurasidone HCl; (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; UNII-22IC88528T
EINECS	Contact for details

Quality Control

Our Lurasidone Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after each use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Limits	Complies with USP <61> and <62>

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