EXTRACTABLES AND LEACHABLES - PHARMACEUTICAL REVIEW

Rajendra Phadke*, Rupali Mali and Dr. Amit Gosar

ABSTRACT

Establishing a link between extractables and leachables must necessary to understand, interpret, assess, quantify, or control the interaction between a drug product and its container/closure system. Extractables and Leachables (E/L) studies help to identify, quantify and minimize harmful impurities which could leach from pharmaceutical container closure systems and packaging into pharmaceutical products. To incorporate quality by design concepts into the management of leachable, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. Since the FDA released their Container Closure Systems for Packaging Human Drugs and Biologics guidance in 1999, evaluation of final packaging components for extractables and leachables has become the expectation within the industry. Additionally, the increase in the use of single-use systems in manufacturing has drawn scrutiny as another potential source of extractables and leachables. These single-use systems include bioprocess bags, filters, tubing, fittings, connectors, bioreactors, etc. Many of these single-use systems are constructed from polymeric materials, increasing the concern of the introduction of leachable compounds to product. This paper considers the applied to evaluate the impact of material composition and processing parameters on extractable profiles and utilized to manage product leachable early in the development process and throughout the product lifecycle hence need to control impurities in drug product.

Keywords: Extractables and Leachables, Container closer, Analytical method development, Isolation and Characterization.