Extractables and Leachables Case Studies

By Barbara Pavan, Ph.D. 

Continuous monitoring of extractables and leachables is of paramount importance in evaluating the safety of a finished product for both the pharmaceutical and consumer products industries. Examining the materials’ extractables over time and across different lots can show how production processes and raw materials sources affect the extractable profile in the finished product. This type of evaluation is critical when products come in contact with the human body for extended periods of time. Leachables evaluation for inhalation drug products is included as part of their stability assessment. Both the nature of the drug and the inherently low detection limits required for inhalation products can make the development and validation of analytical methods particularly challenging. 


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