The Extractables Study: What It Means in the Pharmaceutical Industry

The Extractables Study: What it Means in the Pharmaceutical Industry

Laura Stubbs, Group Leader, West Pharmaceutical Services, Lionville, PA 

The FDA Guidance for Industry: “Container Closure Systems for Packaging Human Drugs and Biologics” states that each application should contain enough information to show that a proposed container closure system and its components are suitable for its intended use. 

 In determining suitability, an extraction study of the components of a container closure system is discussed in relation to patient safety.  The extraction study is the first step in determining chemical species which may potentially leach from the container closure system into a drug dosage form and ultimately be introduced into a patient. 

This type of study is expected by regulatory agencies, but there are no clearly established procedures set forth.  A comprehensive study using a range of extraction solvents, conditions and analytical techniques to determine a wide variety of potential extractables is typically recommended.  Study design is based on risk with the most extensive studies focused on dosage forms with highest safety concern associated with route of administration.   Results of the extractables study can then be used for determination of the path forward to leachables and material control if necessary.