Bempedoic Impurities and its Related Products
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Bempedoic Impurities
Bempedoic acid is a novel drug used to lower cholesterol levels in the blood. During the manufacturing process, impurities may be formed which can affect the quality and efficacy of the drug. These impurities need to be identified, isolated and characterized to ensure the safety and efficacy of the drug. The regulatory authorities have strict guidelines for the permissible levels of impurities in the drug substance and drug product. Therefore, it is important to monitor and control the impurity levels throughout the manufacturing process to ensure the quality of the drug.