Extractable and Leachable Studies


Extractables and leachables studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product. Analytical Solutions offers extractable and leachable testing services through cGMP-compliant procedures. Studies of extractable and leachable components within container closures system are required to meet the safety requirements for marketed medicines. Analytical Solutions undertakes E/L studies for a wide range of drug products in a variety of packaging types, conducted in accordance with various guidelines such as PQRI guidance, USP general Chapter, EMEA etc.

Compounds that are removed from glass, elastomeric, plastic components or coating of the container closure system in the presence of an appropriate solvent(s) under laboratory conditions.

Compounds that migrate from glass elastomeric, plastic components or coatings of the container closure system as results of contact with formulation under normal condition of use.