Following the successful completion of the extraction studies on the container closure system, the development team must now start the process of developing and validating analytical methods for the detection of leachables in the finished drug product.    Regardless of the type of drug product, the development team needs to consider the following:

·               Selection of target leachables

·               Selection of analytical methods and conditions

·               Method sensitivity requirements

·               Drug Product Specific Challenges

Each of these topics will be discussed in separate white papers.    This paper will focus on method sensitivity requirements.

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