Ketotifen is a second-generation antihistamine and mast cell stabilizer used primarily for the management of allergic conditions. It acts mainly by blocking histamine H1 receptors and reducing the release of inflammatory mediators from mast cells.
Ketotifen is available in oral and ophthalmic formulations and is widely studied for allergic disorders, including allergic conjunctivitis and respiratory allergic conditions.
Ketotifen is a specialized antiallergic pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.
Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, residue on ignition and stability.
CAS Number: 34580-13-7
Molecular Formula: C19H19NOS
Molecular Weight: 309.43 g/mol
Drug Class: Antihistamine / Mast Cell Stabilizer
Pharmacological Class: H1 Histamine Receptor Antagonist
Therapeutic Class: Antiallergic Agent
Therapeutic Area: Allergy / Respiratory / Ophthalmology
Ketotifen primarily blocks histamine H1 receptors, reducing the effects of histamine released during allergic reactions.
It also exhibits mast cell-stabilizing properties, which can reduce the release of inflammatory mediators.
Its pharmacological effects include:
Ketotifen is used in formulations for:
The specific indication depends on the formulation and applicable regulatory labeling.
Ketotifen combines antihistaminic activity with mast-cell-stabilizing effects, making it useful in the management of allergic disorders.
Unlike corticosteroids, ketotifen does not primarily act by broad suppression of inflammatory gene transcription; its main pharmacological activity involves histamine receptor antagonism and modulation of mast-cell mediator release.
Typical API manufacturing may involve:
Ketotifen API quality evaluation may include:
Ketotifen should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.
Ketotifen is relevant to research involving:
Ketotifen is a second-generation antihistamine and mast cell stabilizer with CAS Number 34580-13-7, molecular formula C19H19NOS, and molecular weight 309.43 g/mol. It primarily blocks H1 histamine receptors and helps reduce allergic responses and mast-cell mediator release.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |