Identification of Extractables and Leachables Impurities | Veeprho
Identification of Extractables and Leachables Impurities
Extractables are chemical compounds that migrate from any product contact material when exposed to an appropriate solvent under exaggerated conditions of time and temperature.
Leachables are chemical compounds that migrate into the drug formulation from any product contact material, including glass, plastic, stainless steel, elastomeric, or coating components as a result of direct contact with the drug formulation under normal process conditions or accelerated storage conditions and are found in the final drug product. They can increase the toxicity and impurity levels of the drug product and react with product components.
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