Formoterol Fumarate Dihydrate is a long-acting selective beta-2 adrenergic receptor agonist used as an active pharmaceutical ingredient in inhalation medicines. It produces bronchodilation by stimulating beta-2 adrenergic receptors in bronchial smooth muscle.
Formoterol Fumarate Dihydrate API is used in pharmaceutical formulations for the management of respiratory conditions including asthma and chronic obstructive pulmonary disease. It is available as a fumarate salt in the dihydrate form and is recognized in the United States Pharmacopeia (USP) monograph for Formoterol Fumarate.
Formoterol Fumarate Dihydrate has the CAS Number 183814-30-4. The USP molecular composition is represented as (C19H24N2O4)2·C4H4O4·2H2O, with a molecular weight of 840.92 g/mol.
Formoterol selectively stimulates beta-2 adrenergic receptors in bronchial smooth muscle. Activation of these receptors increases intracellular cyclic AMP and promotes relaxation of bronchial smooth muscle, resulting in prolonged bronchodilation.
Formoterol Fumarate Dihydrate is used in pharmaceutical development and inhalation formulations intended for long-term bronchodilator therapy. It is particularly associated with maintenance treatment of asthma and chronic obstructive pulmonary disease.
Formoterol Fumarate Dihydrate is a solid pharmaceutical compound. Commercial analytical material is described as white to off-white, with limited water solubility and solubility in DMSO.
Formoterol Fumarate Dihydrate can be evaluated using infrared identification, HPLC assay, chromatographic purity testing, water determination, residue on ignition, pH and other applicable pharmaceutical quality-control tests. The USP monograph specifies an assay/content range of 98.5%–101.5% on the anhydrous basis.
Formoterol Fumarate Dihydrate should be stored in well-closed, light-resistant containers and handled under controlled pharmaceutical storage conditions. Protection from excessive moisture, heat and direct light is recommended.
Technical documentation for Formoterol Fumarate Dihydrate may include Certificate of Analysis, specification sheet, analytical test results, chromatographic purity data, identification data and other quality documentation required for pharmaceutical development and manufacturing.
Formoterol Fumarate Dihydrate is a beta-2 adrenergic receptor agonist API with CAS Number 183814-30-4 and molecular weight 840.92 g/mol. It is an established pharmaceutical substance with a USP monograph and is used in inhaled medicines for long-term bronchodilator therapy.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms by IR and HPLC retention time |
| Assay (HPLC) | 98.5% – 101.5% on anhydrous basis |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Water Content | 4.0% – 5.0% |
| Melting Point | 116 – 120°C |
| Solubility | DMSO: soluble; Water: insoluble |