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Ketotifen fumarate Ketotifen Ketotifen Hydrogen Fumarate
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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 |
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 |
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.
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