General Information

Theophylline Impurities and Theophylline

Daicel Pharma is a dependable provider of top-notch Theophylline impurity standards, particularly for 1,3-dimethyl uric acid and 3-Methyl Xanthine. These impurities precisely assess the quality, stability, and biological safety of the active pharmaceutical ingredient, Theophylline. Moreover, Daicel Pharma offers a tailored synthesis of Theophylline impurities, ensuring worldwide delivery to cater to the unique requirements of our valued customers.

Theophylline [CAS: 58-55-9] is an orally ingested xanthine derivative prescribed to alleviate symptoms and address reversible airflow obstruction associated with chronic asthma and other chronic respiratory conditions like emphysema and bronchitis.

Theophylline: Use and Commercial Availability   

Theophylline, a xanthine derivative, manages asthma and bronchospasm. It exerts two distinct effects on the airways of individuals with reversible (asthmatic) obstruction. Firstly, it promotes smooth muscle relaxation, leading to bronchodilation. Secondly, it suppresses the airway’s response to stimuli, providing non-bronchodilator prophylactic effects. It treats asthma.

Theophylline is available under Bronkodyl, Duraphyl, Elixicon, Labid, etc., which contains the active ingredient, Theophylline.

Theophylline Structure and Mechanism of Action

The chemical name of Theophylline is 3,9-Dihydro-1,3-dimethyl-1H-purine-2,6-dione. Its chemical formula is C₇H₈N₄O₂, and its molecular weight is approximately 180.16 g/mol.

Theophylline causes bronchodilation by blocking type III and type IV phosphodiesterase (PDE), an enzyme found in smooth muscle cells.

Theophylline Impurities and Synthesis

During the Theophylline preparation¹, impurity formation is possible, compromising its effectiveness. They can arise from various sources, including the raw materials, intermediates, and chemicals utilized to synthesize Theophylline. Close management and monitoring of impurities ensure the drug’s efficacy and safety.

Daicel offers a wholesome and integrated Certificate of Analysis (CoA) for Theophylline impurity standards, encompassing 1,3-dimethyl uric acid and 3-Methyl Xanthine. The CoA provides detailed characterization data, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Additionally, we give a detailed 13C-DEPT on delivery. With advanced technology and expertise, Daicel can synthesize any unknown Theophylline impurity or degradation product.