Leachables from sample container closure systems from primary and secondary packaging component that migrate into a drug products have a potentially negative impact on safety. This white paper describes how to evaluate this risk through the proper design of an extraction study and the following analysis of leachables in the drug product.
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.
