Description

Zotepine is a dibenzothiepine-class atypical antipsychotic agent, primarily recognized for its potent antagonistic activity at dopamine D2 and serotonin 5-HT2A receptors. This pharmacological profile makes it a critical active pharmaceutical ingredient (API) for the formulation of medications targeting schizophrenia and related psychotic disorders. It is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of advanced neuropsychiatric therapeutics. The compound is supplied under stringent quality controls to ensure reliability for commercial and investigational use.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antipsychotic medications for treating schizophrenia.
• Neuropharmacology Research: A key reference standard in preclinical and clinical studies investigating the mechanisms of atypical antipsychotics.
• Formulation Development: Used in R&D for creating various dosage forms, including tablets and capsules.
• Generic Drug Production: Serves as the core component for generic pharmaceutical companies producing zotepine-based products.
• Analytical Reference Standard: Employed in quality control laboratories for HPLC, LC-MS, and other analytical method development and validation.
• Chemical Intermediate: Potential use in the synthetic pathways for creating novel, related therapeutic compounds.

Basic Information

Product Name	Zotepine
CAS No.	26615-21-4
Molecular Formula	C18H18ClNOS
Molecular Weight	331.86 g/mol
Synonyms	Zotepine; Lodopin; Nipolept; 2-[(8-Chlorodibenzo[b,f]thiepin-10-yl)oxy]-N,N-dimethylethanamine; FR-1314; CL-183,532; CL-183532; CL 183532
EINECS	Contact for details

Quality Control

Our Zotepine is manufactured and tested to meet the rigorous standards required for pharmaceutical active ingredients. Quality assurance protocols are aligned with current Good Manufacturing Practices (cGMP). Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring traceability and compliance for global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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