Description

Emedastine Fumarate is a selective histamine H1-receptor antagonist, primarily utilized as an active pharmaceutical ingredient (API). Its core value lies in its potent and specific anti-allergic activity, making it a critical component in ophthalmic solutions for treating allergic conjunctivitis. This high-purity compound is essential for pharmaceutical manufacturers and R&D facilities focused on developing and producing advanced ophthalmic medications. The global market for this API is driven by demand for effective, targeted allergy treatments.

Application

• Primary Active Pharmaceutical Ingredient (API) in prescription ophthalmic solutions and eye drops for allergic conjunctivitis.
• Research & Development of novel anti-allergic and anti-inflammatory drug formulations.
• Pharmaceutical Intermediates for the synthesis of more complex therapeutic agents.
• Reference Standard in analytical laboratories for quality control and method validation.
• Clinical Trial Material for studies investigating new indications or delivery methods.

Basic Information

Product Name	Emedastine Fumarate
CAS No.	87233-62-3
Molecular Formula	C17H26N2O3 • C4H4O4
Molecular Weight	534.59 g/mol
Synonyms	Emedastine Difumarate; 1-(2-Ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)-1H-benzimidazole Difumarate; Emedastine (as difumarate); WAL 801 CL; CAS 87233-61-2 (free base); Alegysal (brand name ophthalmic solution); 1H-Benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)-, (2E)-2-butenedioate (1:2)
EINECS	Contact for details

Quality Control

Our Emedastine Fumarate is manufactured under strict quality systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopeial standards. Each batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling. A Certificate of Analysis (COA) detailing all test results is provided to ensure full traceability and support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

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%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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