Description

Epinastine Hydrochloride CAS NO 108929-04-0 is a selective histamine H1-receptor antagonist with mast cell-stabilizing properties. This compound is of significant commercial and therapeutic importance as an active pharmaceutical ingredient (API) for the treatment of allergic conditions. It is primarily required by pharmaceutical manufacturers for the formulation of ophthalmic solutions and nasal sprays, targeting markets in allergy and ophthalmology.

Application

• Primary Active Pharmaceutical Ingredient (API) in ophthalmic solutions for allergic conjunctivitis.
• Key component in nasal spray formulations for the relief of allergic rhinitis symptoms.
• Intermediate in the synthesis of advanced pharmaceutical derivatives and novel drug formulations.
• Reference standard in analytical laboratories for quality control and method development.
• Raw material for clinical research and development of new anti-allergic therapeutics.
• Used in stability studies and compatibility testing for drug product development.

Basic Information

Product Name	Epinastine Hydrochloride
CAS No.	108929-04-0
Molecular Formula	C16H15N3•HCl
Molecular Weight	285.77 g/mol
Synonyms	Epinastine HCl; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine Hydrochloride; WAL 801 HCl; (+-)-Epinastine Hydrochloride; 1H-Dibenz[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrochloride, (±)-; Relestat (brand name); Alesion (brand name)
EINECS	Contact for details

Quality Control

Our Epinastine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are provided with every shipment.

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 dry environment to prevent moisture absorption.

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)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%

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