Sildenafil citrate IP is a white to off-white crystalline powder, practically insoluble in water, but soluble in methanol and ethanol. Its chemical formula is C22H30N6O4S. This compound features a pyrazolopyrimidine core structure, crucial for its pharmacological activity. The citrate salt improves its solubility and stability compared to the free base form.
Molecular Structure and Properties
The molecule possesses several key functional groups influencing its properties. These include a piperazine ring, a sulfonyl group, and an amide group. These groups interact with specific enzymes in the body, leading to its therapeutic effects. The precise arrangement of these groups is critical for its selective action as a phosphodiesterase-5 (PDE5) inhibitor. A high purity of Sildenafil Citrate IP is required for consistent pharmacological action.
Manufacturing and Quality Control
Manufacturing involves careful synthesis and purification steps to achieve the desired high purity. Stringent quality control measures, including high-performance liquid chromatography (HPLC) and other spectroscopic techniques, confirm purity and identify any potential impurities. These methods ensure the final product conforms to the required pharmaceutical standards. Compliance with Good Manufacturing Practices (GMP) is mandatory throughout the process.
