CAS: 2164516-85-0

Sofosbuvir impurity I is an organic chemical impurity often associated with the active pharmaceutical ingredient (API) Sofosbuvir, which is used in the treatment of hepatitis C. This impurity arises during the manufacturing process of Sofosbuvir as a byproduct. It is crucial to monitor and identify such impurities to ensure the safety, efficacy, and quality of the final pharmaceutical product. The mode of action of Sofosbuvir impurity I is not directly therapeutic but instead relevant to the manufacturing controls and quality assurance processes of drug production. Analyzing and managing these impurities is essential for pharmaceutical development, allowing scientists to maintain compliance with regulatory standards and optimize the purification steps involved in the API synthesis. Uses and applications of Sofosbuvir impurity I primarily relate to its role in analytical testing and validation processes. It serves as a reference standard in quality control laboratories to quantify and control impurity levels in drug formulations, ensuring that the levels remain within safe and acceptable limits. Understanding and managing impurities like Sofosbuvir impurity I are vital for maintaining the integrity of the pharmaceutical manufacturing process.