Description

Setastine Hydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the development and manufacture of antihistamine medications. Its value lies in providing a reliable, well-characterized building block for producing effective therapeutic agents targeting allergic conditions. This compound is essential for pharmaceutical manufacturers and R&D organizations focused on respiratory and dermatological treatments, ensuring stringent quality and supply chain integrity for critical drug production processes.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the formulation of antihistamine drugs.
• Allergy Medication Production: Key intermediate for manufacturing tablets, capsules, and other oral dosage forms targeting allergic rhinitis and chronic urticaria.
• Clinical Research & Development: Serves as a reference standard and raw material in preclinical and clinical studies for new therapeutic entities.
• Generic Drug Manufacturing: Critical for companies producing bioequivalent versions of branded antihistamine medications.
• Veterinary Pharmaceutical Applications: Used in developing antihistamine treatments for allergic conditions in animals.

Basic Information

Product Name	Setastine Hydrochloride
CAS No.	59767-13-4
Molecular Formula	C22H28ClNO
Molecular Weight	357.92 g/mol
Synonyms	1-(2-(4-(1,1-Dimethylethyl)phenyl)ethyl)hexahydro-4-methyl-1H-azepin-4-ol Hydrochloride; Loderix; Setastine HCl; PMS-Setastine; Setastinum Hydrochloridum; NSC 339539; SQ-10924
EINECS	Contact for details

Quality Control

Our Setastine Hydrochloride is manufactured under strict quality management systems, with purity typically meeting or exceeding 98.5% (HPLC). Each batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure compliance with ICH guidelines and customer-specific requirements. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment.

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. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Any individual impurity ≤ 0.5%; Total impurities ≤ 1.0%

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