Description

Epinastine CAS NO 80012-43-7 is a selective histamine H1-receptor antagonist with additional anti-allergic properties. This compound is of significant commercial and therapeutic importance as a key active pharmaceutical ingredient (API) in ophthalmic and systemic anti-allergic medications. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for allergic conjunctivitis, rhinitis, and other hypersensitivity disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription ophthalmic solutions for allergic conjunctivitis.
• Systemic Antihistamines: Formulation into oral tablets or syrups for the treatment of allergic rhinitis and chronic urticaria.
• Veterinary Medicine: Development of anti-allergic treatments for companion animals.
• Clinical Research: Used as a reference standard in pharmacological studies of histamine receptor antagonism.
• Drug Discovery: Serves as a chemical scaffold for synthesizing novel anti-allergic compounds with improved efficacy.
• Generic Drug Manufacturing: Sourcing for the production of cost-effective generic versions of branded anti-allergy drugs.

Basic Information

Product Name	Epinastine
CAS No.	80012-43-7
Molecular Formula	C16H15N3
Molecular Weight	249.31 g/mol
Synonyms	Epinastine Hydrochloride; WAL 801 HCl; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride; (+-)-Epinastine; (RS)-Epinastine; (±)-Epinastine; Alesion (brand name); Relestat (brand name)
EINECS	Contact for details

Quality Control

Our Epinastine is manufactured under strict quality management systems. We provide material that meets or exceeds the specifications of major pharmacopoeias, including USP and EP monographs where applicable. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance for GMP-driven pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

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)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%

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