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Leachables are compounds that leach into the drug or. biological product from the container-closure system - such. as the elastomeric or plastic components, or coatings of the. container and closure system. Leaching is mainly as a result of direct contact with the. formulation under normal conditions of use.
Page 2 of 12 ABSTRACT A universal approach for determining the extractable and leachable metals in pharmaceutical products by Inductively Coupled Plasma Mass Spectrometry (ICPMS) is investigated.lso, certain metals at extremely low levels may not be detected, thus there is the potential for their presence in the drug product to go unnoticed. The universal approach involves a complete acid digestion of the packaging material and drug product. Sample solutions are then analysis by ICPMS.