Description

Epinastine Hydrobromide is a selective H1-antihistamine and mast cell stabilizer, recognized for its dual mechanism of action. This compound is of significant commercial and therapeutic importance in the pharmaceutical industry, particularly for ophthalmic applications. It is primarily required by manufacturers of prescription and over-the-counter (OTC) medications targeting allergic conjunctivitis and other hypersensitivity reactions.

Application

• Ophthalmic Solutions: As the active pharmaceutical ingredient (API) in prescription and OTC eye drops for the treatment of allergic conjunctivitis, providing relief from itching and redness.
• Pharmaceutical Intermediates: Serves as a key synthetic intermediate in the production of more complex antihistaminic drugs and related pharmacologically active molecules.
• Research & Development: Utilized in preclinical and clinical research studies investigating histamine receptor antagonists and mast cell stabilization mechanisms.
• Veterinary Medicine: Potential application in veterinary ophthalmic preparations for managing allergic conditions in animals.
• Formulation Development: Used by pharmaceutical formulators for developing new dosage forms, such as nasal sprays or topical creams, leveraging its antihistaminic properties.
• Reference Standard: Supplied as a high-purity analytical standard for quality control (QC) and regulatory testing in pharmaceutical manufacturing and analytical laboratories.

Basic Information

Item	Detail
Product Name	Epinastine Hydrobromide
CAS No.	127786-29-2
Molecular Formula	C16H15N3 • HBr
Molecular Weight	338.22 g/mol
Synonyms	Epinastine HBr; 3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrobromide; WAL 801 HCl (obsolete); (+-)-Epinastine hydrobromide; (RS)-Epinastine hydrobromide; 1H-Dibenz[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrobromide; Alesion (brand name related)
EINECS	Contact for details

Quality Control

Our Epinastine Hydrobromide is manufactured and tested under a strict quality management system. We provide material that meets high-purity standards suitable for pharmaceutical R&D and manufacturing. Certificates of Analysis (COA) detailing identity, purity, and impurity profiles are available for every batch upon request, ensuring full traceability and compliance with your project requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%

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