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Sildenafil Citrate Impurities
Sildenafil citrate is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. However, during the manufacturing process, impurities may be introduced into the drug substance or product. These impurities can be harmful to human health and must be monitored and controlled to ensure the safety and efficacy of the medication. Regulatory agencies such as the FDA and EMA have established guidelines for acceptable levels of impurities in sildenafil citrate and other pharmaceuticals. Analytical techniques such as HPLC and GC are used to detect and quantify impurities in drug products.