Description

Ketotifen Fumarate is a selective, non-competitive histamine H1-antagonist and mast cell stabilizer. This active pharmaceutical ingredient (API) is critical for its potent anti-allergic and anti-inflammatory properties, making it a key component in therapeutic formulations. It is primarily required by pharmaceutical manufacturers for the production of ophthalmic solutions and oral medications targeting allergic conditions such as conjunctivitis and asthma.

Application

• Pharmaceutical API: Primary active ingredient in anti-allergic ophthalmic solutions (eye drops).
• Oral Solid Dosage Forms: Used in the manufacture of tablets and syrups for the prophylactic treatment of bronchial asthma and allergic disorders.
• Mast Cell Stabilizer Formulations: Key component in medications designed to inhibit the release of histamine and other inflammatory mediators.
• Veterinary Pharmaceuticals: Applied in treatments for allergic conditions in animals.
• Research & Development: Serves as a reference standard and building block in pharmacological and biochemical research.
• Intermediate for Derivatives: Used in synthetic chemistry for the development of novel therapeutic agents.

Basic Information

Product Name	Ketotifen Fumarate
CAS No.	34580-14-8
Molecular Formula	C23H23NO5S
Molecular Weight	425.50 g/mol
Synonyms	Ketotifen Hydrogen Fumarate; 4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one hydrogen fumarate; Zaditen; HC 20-511; Fumaric acid ketotifen salt; Ketotifenum; Ketotifeno; Ketotifene
EINECS	Contact for details

Quality Control

Our Ketotifen Fumarate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each batch to guarantee supply reliability and product consistency for our global B2B clients.

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 maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Specific Rotation	Contact for details

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