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One of the primary concerns surrounding residual solvents is their impact on drug safety. Many of these solvents have been linked to serious health risks, including carcinogenicity, reproductive toxicity, and organ damage. As such, regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established stringent guidelines for the permissible levels of residual solvents in pharmaceutical products. Compliance with these guidelines is essential for manufacturers to ensure that their products meet safety standards and gain market approval.
residual solvents

Potassium sorbate, also known as sorbistat-k, E-202 and sorbistat-potasium, is a white, odorless, and tasteless salt. Although it is naturally occurring in some fruits like berries, it is commercially produced by a neutralization reaction between sorbic acid and potassium hydroxide. It is an inactive salt form of sorbic acid and just like sorbic acid, it has been found to be active against molds, yeasts, bacteria and fungi. Because of these antimicrobial activities, it is often used as a preservative in the food and beverage industries to preserve foods like cheese, yogurt, dried meat, bread, cake, milkshakes, pickles, ice cream and apple cider.