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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
