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.

Extractables:
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.

Leachables:
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.