Following the successful completion of the extraction studies on the container closure systems, 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:
Each of these topics will be discussed in separate white papers. This paper will focus on the selection of analytical methods and conditions.
Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing laboratory. Our lab, located in Bristol, CT, is FDA registered and inspected and DEA licensed for Schedules 1 through V.
