Description

Ebastine Fumarate is a high-purity active pharmaceutical ingredient (API) belonging to the class of second-generation, non-sedating antihistamines. It is the fumarate salt form of Ebastine, offering enhanced stability and bioavailability for pharmaceutical manufacturing. This compound is critical for formulators and manufacturers developing advanced allergy and urticaria treatments. Its primary application is in the production of oral solid dosage forms for the global pharmaceutical market.

Application

• Pharmaceutical API: Primary active ingredient in prescription and OTC antihistamine medications.
• Allergy Treatment Formulations: Used in tablets and capsules for the symptomatic relief of seasonal allergic rhinitis (hay fever).
• Chronic Idiopathic Urticaria Treatment: Key component in medications designed to alleviate symptoms of chronic hives.
• Drug Product Development: Serves as a reference standard and raw material in R&D for new antihistamine drug products.
• Generic Drug Manufacturing: Essential for producing bioequivalent generic versions of branded Ebastine medications.
• Veterinary Pharmaceuticals: Potential application in developing antihistamine treatments for animal health.

Basic Information

Product Name	Ebastine Fumarate
CAS No.	97928-20-6
Molecular Formula	C32H39NO4 • C4H4O4
Molecular Weight	585.69 g/mol
Synonyms	Ebastine Fumarate; Ebastine (E)-Butenedioate; 1-[4-(1,1-Diphenylethoxy)butyl]-4-piperidinecarboxylic Acid 4-(Diphenylmethoxy)-1-piperidinebutyl Ester Fumarate; LAS-W 090; LAS W090; 4'-tert-Butyl-4-[4-(diphenylmethoxy)piperidino]butyrophenone Fumarate; Ebastine Hydrogen Fumarate
EINECS	Contact for details

Quality Control

Our Ebastine Fumarate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmacopeial standards, including identification, purity, assay, and impurity profile. A Certificate of Analysis (COA) detailing all test results is provided with every shipment. We support compliance with major international standards, including ICH guidelines, and can supply material suitable for use in regulated markets.

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. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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