Description

Epinastine Hydrochloride CAS NO 80012-44-8 is a selective histamine H1-receptor antagonist with mast cell-stabilizing properties. This dual-action mechanism makes it a highly effective active pharmaceutical ingredient (API) for managing allergic conditions. It is primarily utilized by pharmaceutical manufacturers in the development and production of ophthalmic solutions and nasal sprays for the treatment of allergic conjunctivitis and allergic rhinitis.

Application

• Ophthalmic Solutions: Primary API for prescription and over-the-counter (OTC) eye drops targeting allergic conjunctivitis, providing rapid relief from itching, redness, and watering.
• Nasal Sprays: Key ingredient in formulations designed to alleviate symptoms of seasonal and perennial allergic rhinitis, including sneezing, nasal congestion, and rhinorrhea.
• Pharmaceutical R&D: Used in preclinical and clinical research for developing novel anti-allergy medications and exploring new therapeutic applications.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for the production of bioequivalent versions of branded anti-allergy treatments.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for managing allergic reactions in companion animals.
• Formulation Studies: Employed in stability testing, excipient compatibility studies, and the development of controlled-release or combination drug delivery systems.

Basic Information

Product Name	Epinastine Hydrochloride
CAS No.	80012-44-8
Molecular Formula	C16H15N3·HCl
Molecular Weight	285.77 g/mol
Synonyms	Epinastine HCl; WAL 801 HCl; (+)-3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine Hydrochloride; (3aS)-3,3a,4,5-Tetrahydro-2H-benz[4,5]imidazo[1,2-a]azepin-2-amine Hydrochloride; 1H-Dibenz[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrochloride, (3aS-cis)-; Alesion (brand name); Relestat (brand name); Elestat (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 stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. We provide full traceability and support regulatory submissions with comprehensive documentation. Certificates of Analysis (COA) are available upon request.

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 low-humidity environment to prevent moisture absorption, which can affect stability and handling properties.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	+56° to +60° (c=1 in methanol)

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