Diphylline is a pharmaceutical active pharmaceutical ingredient (API) belonging to the xanthine derivative class. It is a bronchodilator used in pharmaceutical formulations for the management of bronchospasm associated with respiratory conditions.
Diphylline, also known as dyphylline, is a water-soluble xanthine derivative related to theophylline. It produces bronchodilatory effects by relaxing bronchial smooth muscle and helping improve airflow through the respiratory tract.
Diphylline is a small-molecule pharmaceutical API used in the manufacture of oral and injectable formulations. Its water solubility distinguishes it from some other xanthine derivatives and makes it suitable for selected pharmaceutical formulations.
Diphylline produces bronchodilation primarily through inhibition of phosphodiesterase activity and antagonism of adenosine-mediated effects, resulting in relaxation of bronchial smooth muscle and improved airway function.
Diphylline API is used in pharmaceutical formulations for:
Specific approved uses depend on the formulation and applicable regulatory labeling.
Diphylline is generally supplied as a white crystalline powder. It is a hydrophilic xanthine derivative with substantially greater water solubility than theophylline.
Diphylline API intended for pharmaceutical manufacturing should be produced under appropriate GMP controls and tested according to applicable quality and regulatory requirements. Quality evaluation may include identity, assay, related substances, water content, residual solvents, elemental impurities and other relevant quality attributes.
Diphylline is a pharmaceutical bronchodilator API used in respiratory formulations. Pharmaceutical manufacturers and formulation developers can evaluate Diphylline based on applicable regulatory requirements, analytical documentation, quality specifications and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |