Mizolastine is a second-generation antihistamine and selective histamine H1-receptor antagonist used in pharmaceutical development for the management of allergic conditions. It is a synthetic small-molecule API with antihistaminic activity and is primarily associated with the treatment of allergic rhinitis and urticaria.
Mizolastine has the CAS Number 108612-45-9, molecular formula C24H25FN6O, and molecular weight 416.49 g/mol. It is a chemically defined pharmaceutical compound used in the development and manufacture of oral antihistamine formulations.
Mizolastine is a specialized antihistamine pharmaceutical API used for formulation development and pharmaceutical manufacturing. Its quality profile can include controls for identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable pharmaceutical quality attributes.
CAS Number: 108612-45-9
Molecular Formula: C24H25FN6O
Molecular Weight: 416.49 g/mol
Chemical Class: Piperidine Derivative
Drug Class: Second-Generation Antihistamine
Therapeutic Class: H1-Receptor Antagonist
Therapeutic Area: Allergy / Immunology
Molecule Type: Synthetic Small Molecule
Mizolastine acts primarily as a selective histamine H1-receptor antagonist. By blocking histamine H1 receptors, it reduces the effects of histamine released during allergic reactions.
This action helps reduce symptoms such as sneezing, itching, nasal discharge and other manifestations associated with allergic conditions.
Mizolastine API is used in pharmaceutical development for:
Mizolastine is particularly relevant to pharmaceutical products targeting histamine-mediated allergic symptoms. As a second-generation antihistamine, it was developed to provide peripheral H1-receptor blockade for allergic conditions.
Mizolastine is a synthetic crystalline pharmaceutical compound. Its appearance, particle-size characteristics, polymorphic properties and other physical attributes should be controlled according to the applicable API specification and validated analytical procedures.
A controlled Mizolastine API manufacturing process may involve:
Typical Mizolastine API quality testing may include:
Store Mizolastine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should follow validated stability data and the applicable approved API specification.
Mizolastine is relevant to research involving:
Mizolastine is a second-generation H1 antihistamine API with CAS Number 108612-45-9, molecular formula C24H25FN6O, and molecular weight 416.49 g/mol. It acts primarily through selective antagonism of histamine H1 receptors and is associated with pharmaceutical development for allergic rhinitis and urticaria.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 0.5% |