Description

Ketotifen is a benzocycloheptathiophene derivative with potent antihistaminic and mast cell-stabilizing properties. This active pharmaceutical ingredient (API) is critical for the development and production of ophthalmic and systemic anti-allergic medications. It is primarily utilized by pharmaceutical manufacturers and research institutions in the global healthcare sector for its efficacy in preventing and treating allergic conditions such as allergic conjunctivitis and asthma.

Application

• Pharmaceutical API: Primary use as the active ingredient in ophthalmic solutions (eye drops) for the treatment of allergic conjunctivitis.
• Systemic Anti-Allergic Formulations: Used in oral tablets and syrups for the long-term management and prophylaxis of mild allergic asthma and other allergic disorders.
• Mast Cell Stabilizer: Functions to inhibit the release of histamine and other inflammatory mediators from mast cells, preventing allergic reactions.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological research for developing new anti-allergic and anti-inflammatory therapies.
• Veterinary Medicine: Applied in formulations for managing allergic conditions in animals.
• Combination Therapies: Investigated for use in combination with other agents to enhance therapeutic outcomes in chronic allergic diseases.

Basic Information

Product Name	Ketotifen
CAS No.	34580-13-7
Molecular Formula	C19H19NOS
Molecular Weight	309.43 g/mol
Synonyms	4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-10(9H)-one; Zaditen; HC 20-511; Ketotifenum; Ketotifeno; Ketotifenum [Latin]; Ketotifene; Ketotifenum
EINECS	Contact for details

Quality Control

Our Ketotifen is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including identification, purity assay, and impurity profiling to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with every shipment.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

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.