Formoterol Impurities and Formoterol
Daicel Pharma synthesizes more than twenty high-quality Formoterol impurities, including (R, R)-Formoterol, (S, R)-Formoterol, (S, S)-Formoterol, N-Benzyl Formoterol, rac-O-Benzyl N-Benzyl Formoterol, Formoterol (mixture of Diastereomers), Formoterol related compound I, etc., which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient, Formoterol. Moreover, Daicel Pharma offers custom synthesis of Formoterol impurities and delivers them globally.
Formoterol [CAS:73573-87-2] is a bronchodilator medicine that acts as a long-acting beta-2 adrenergic receptor agonist. It helps in the maintenance treatment of asthma and the prevention of bronchospasm.
Formoterol: Use and Commercial Availability
Formoterol treats asthma and chronic obstructive pulmonary disease (COPD) in various formulations. For COPD treatment, Formoterol can be administered alone or in combination with long-acting muscarinic antagonists (LAMAs) or corticosteroids. For asthma treatment, Formoterol combines with mometasone furoate or budesonide for patients of different ages. Formoterol can act as a prophylaxis agent against exercise-induced bronchospasm. Formoterol is available under brand names, including Symbicort, Perforomist, Foradil, Dulera, Brovana, Breyna, etc.
Formoterol Structure and Mechanism of Action
The chemical name of Formoterol is rel-N-[2-Hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide. Its chemical formula is C19H24N2O4, and its molecular weight is approximately 344.4 g/mol.
Formoterol selectively binds to beta-2 adrenergic receptors in the bronchial smooth muscles. It stimulates intracellular adenyl cyclase, an enzyme. Formoterol catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3′,5′-adenosine monophosphate (cAMP). Increased cAMP causes relaxation of the bronchial smooth muscles and reduces bronchospasms.
Formoterol Impurities and Synthesis
Formoterol impurities preparation help in the identification, quantification, and evaluation of the chemical properties and stability of the drug. It can also help in the development of analytical methods and regulatory compliance. The information obtained from the synthesis of impurities is crucial for drug safety, efficacy, and quality control. So, the synthesis1 of Formoterol impurities plays a significant role in pharmaceutical research and development.
Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for more than 20 Formoterol impurity standards, including (R, R)-Formoterol, (S, R)-Formoterol, (S, S)-Formoterol, N-Benzyl Formoterol, rac-O-Benzyl N-Benzyl Formoterol, Formoterol (mixture of Diastereomers), Formoterol related compound I, etc. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS2, and HPLC purity. We also provide 13C-DEPT and CHN on request. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Formoterol impurity or degradation product.
- Trofast, Jan; Oesterberg, Kristina; Kaellstroem, Britt Louise; Waldeck, Bertil, Steric aspects of agonism and antagonism at β-adrenoceptors: synthesis and pharmacological experiments with the enantiomers of formoterol and their diastereomers, Chirality, Volume: 3, Issue: 6, Pages: 443-50, 1991
Frequently Asked Questions
What are the sources of Formoterol impurities?
The sources of impurities in Formoterol include degradation products during manufacturing and storage, raw materials used during manufacturing, and contaminants during the manufacturing process. Other potential sources include residual solvents and reagents used in synthesis and impurities in the drug delivery device or packaging.
What is the purpose of synthesizing Formoterol impurities?
The purpose of synthesizing Formoterol impurities is to identify, characterize, and quantify the impurities present in Formoterol drug products. It assesses Formoterol's safety, efficacy, and quality while ensuring compliance with regulatory guidelines.
How are Formoterol impurities detected and quantified?
Formoterol impurities are typically detected and quantified using analytical methods such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS).
What is the solvent used for the analysis of Formoterol impurities?
The polar solvent methanol helps in analyzing Formoterol and its impurities.
What are the temperature conditions required to store Formoterol impurities?
Formoterol impurities should be stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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