What Types of Impurities may be Present in Active Substances?
Special risks in the production of chemical active substances are contamination with organic impurities (starting materials, intermediates, by-products and degradation products), inorganic impurities (elemental impurities) and residual solvents. Adequate treatment of these risks has to be proven by documented risk management and appropriate risk control strategies in the registration documents as well as by on-site audits.
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