Description

Lumateperone (Tosylate) CAS NO 1187020-80-9 is a high-purity active pharmaceutical ingredient (API) and a key chemical intermediate in modern pharmaceutical synthesis. This compound is critical for research and development in neuropsychiatric therapeutics, offering a pathway to innovative treatments. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development of central nervous system (CNS) agents and novel antipsychotic medications.

Application

• Pharmaceutical API Synthesis: Serves as the active pharmaceutical ingredient in the manufacture of finished dosage forms.
• Neurological Research: Used as a reference standard and investigational compound in preclinical and clinical studies targeting serotonin and dopamine receptors.
• Process Development: Acts as a critical intermediate for chemists optimizing scalable and cost-effective synthetic routes for new chemical entities (NCEs).
• Analytical Standard: Employed in quality control laboratories for method development, validation, and as a purity benchmark in HPLC, LC-MS, and NMR analyses.
• Formulation Studies: Utilized in the development of stable and bioavailable drug formulations, including tablets and capsules.
• Regulatory Submissions: Provides the necessary certified reference material for drug master file (DMF) compilation and regulatory compliance dossiers for agencies like the FDA and EMA.

Basic Information

Item	Detail
Product Name	Lumateperone (Tosylate)
CAS No.	1187020-80-9
Molecular Formula	C₂₉H₃₂FN₃O₃S
Molecular Weight	521.65 g/mol
Synonyms	ITI-007 Tosylate; (1R,4S)-N-[(1R)-1-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-yl]ethyl]cyclohexane-1,4-diamine 4-methylbenzenesulfonate; (1R,4S)-N-[(1R)-1-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-yl]ethyl]cyclohexane-1,4-diamine p-toluenesulfonate; Lumateperone 4-Methylbenzenesulfonate; ITI-007 Tosylate Salt
EINECS	Contact for details

Quality Control

Our Lumateperone (Tosylate) 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, consistent 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 place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment and sealed immediately after use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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