Product Information   Product name Ketotifen hydrogen fumarate CAS No. 34580-14-8 Molecular Formula C23H23NO5S Molecular Weight 425.505 Quality Standard 98.5% up by HPLC Appearance White to brownish-yellow, fine crystalline powder   COA   ANALYSIS SPECIFICATION RESULTS Appearance White to brownish-yellow, fine crystalline powder Almost white fine crystalline powder Identification The infrared absorption spectrum of the sample is concordant with the reference standard Conforms Clarity and colour of solution The solution is clear and not more intensity coloured than reference solution Y4, BY4 or B4. Conforms Loss on drying ≤0.5% < 0.1% Sulfated ash ≤0.1% < 0.1% Assay(Titration) ≤20ppm <20ppm Related substances (by HPLC) Impurity A ≤ 0.2% 0.06% Impurity G ≤ 0.15% <LOD Any unspecified impurity ≤ 0.10% <LOD Total impurities ≤ 0.3% 0.06% Conclusion The product complies with R1-CEP 2004-269-Rev 01   Usage   What is Ketotifen fumarate? Ketotifen hydrogen fumarate is an antihistamine and mast cell stabilizer medication. It's primarily used to manage allergic conditions such as allergic conjunctivitis (itchy, watery eyes due to allergies) and asthma.   Its functions include:   Antihistamine: Ketotifen works by blocking the effects of histamine, a substance produced by the body during an allergic reaction. By inhibiting histamine, it helps alleviate symptoms like itching, redness, and swelling.   Mast Cell Stabilization: It also stabilizes mast cells, which are involved in allergic reactions. Mast cells release histamine and other inflammatory substances when triggered by allergens. Ketotifen helps prevent these cells from releasing these substances, reducing the severity of allergic reactions.   Ketotifen is available in various forms, including eye drops for allergic conjunctivitis and oral preparations for asthma and other systemic allergic conditions. As with any medication, it's essential to use Ketotifen as prescribed by a healthcare professional to achieve the best results and minimize potential side effects. *Products under the patent are only for R&D use