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Salmeterol
General Information
Salmeterol Impurities and Salmeterol
Daicel Pharma offers a comprehensive range of exclusive Salmeterol impurities such as Salmeterol EP Impurity G, Dimethyl-4-(benzyloxy)isophthalate,(4-(benzyloxy)-1,3-phenylene)dimethanol, Alpha-Hydroxy salmeterol, Benzylated amino methyl impurity of SAM-V, Salmeterol Related Impurity-2, Salmeterol Related Impurity-4, Salmeterol Related impurity-5, Salmeterol Related Impurity 7, and more. These impurities are critical in determining the active pharmaceutical ingredient Salmeterol’s quality, stability, and biological safety. Additionally, Daicel Pharma can synthesize Salmeterol impurities according to precise customer specifications while guaranteeing worldwide delivery.
Salmeterol [CAS: 89365-50-4] is a long-acting beta-agonist (LABA) medication for treating asthma with an inhaled corticosteroid. It prevents exercise-induced bronchospasm. In addition, Salmeterol is used to maintain airflow obstruction and prevent exacerbations in individuals with chronic obstructive pulmonary disease (COPD).
Salmeterol: Use and Commercial Availability
Salmeterol is a maintenance therapy for COPD to help maintain airflow and prevent exacerbations. It is a long-acting beta-agonists (LABAs). Salmeterol relaxes and opens the airways, making breathing easier. It is a part of combination therapy, alongside an inhaled corticosteroid, for better management of asthma or COPD symptoms. Salmeterol is available under many brand names. Serevent effectively contains the active ingredient – Salmeterol.
Salmeterol Structure and Mechanism of Action 
The chemical name of Salmeterol is 4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol. Its chemical formula is C25H37NO4, and its molecular weight is approximately 415.6 g/mol.
Salmeterol is a selective beta2-adrenoceptor that causes bronchial smooth muscle relaxation, bronchodilation, and increased airflow.
Salmeterol Impurities and Synthesis
Impurities can arise during the synthesis1 and storage of Salmeterol, including related substances, degradation products, or residual solvents. These impurities must be monitored and controlled to ensure the medication’s safety, efficacy, and quality.
Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Salmeterol impurity standards like Salmeterol EP Impurity G, Dimethyl-4-(benzyloxy)isophthalate,(4-(benzyloxy)-1,3-phenylene)dimethanol, Alpha-Hydroxy salmeterol, Benzylated amino methyl impurity of SAM-V, Salmeterol Related Impurity-2, Salmeterol Related Impurity-4, Salmeterol Related impurity-5, Salmeterol Related Impurity 7, and more. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional characterization data, including 13C-DEPT, upon request. Daicel Pharma offers to generate unknown impurities or degradation products of Salmeterol.
References
FAQ's
References
- Skidmore, Ian Frederick; Lunts, Lawrence Henry Charles; Finch, Harry; Naylor, Alan, Phenethanolamine derivatives, Glaxo Group Ltd., United Kingdom, GB2140800A, December 5, 1984
- Kim, Kyeong Ho; Yun, Hyeong Won; Kim, Hyun Ju; Park, Hyun Ji; Choi, Pok Wah, Coupled column chromatography in chiral separation of salmeterol, Archives of Pharmacal Research Volume: 21, Issue: 2, Pages: 212-216, 1998
Frequently Asked Questions
How are Salmeterol impurities detected and quantified?
Methods such as gradient Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) and preparative HPLC can detect impurities in Salmeterol.
Can Salmeterol impurities affect patient safety?
Yes, impurities in Salmeterol can impact patient safety. Depending on their nature and concentration, contaminants can cause adverse effects or reduce the efficacy of the medication.
Which solvents help in the analysis of Salmeterol impurities
Methanol achieves optimal solubility and separation of Salmeterol impurities. However, the choice of solvent depends on the specific impurity analyzed and the analytical technique employed.
What are the temperature conditions required to store Salmeterol impurities?
Salmeterol 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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