GMP Lab Extractables and Leachables Publications


The evaluation of extractables and leachables (E&L) is an increasingly important component of the pharmaceutical development process. To support E&L testing, we employ more than 40 scientists, maintain 10,000 square feet of laboratory space and utilize state-of-the-art instrumentation that includes GC/MS, LC/MS and ICP-MS systems.

Compounds that migrate to the drug product from the manufacturing process components, the final container/closure packaging or product administration components could be harmful to the patient or cause patient safety issues and adversely impact the efficacy of the product.

The scrutiny and expectations for evaluating E&L have extended beyond where they were only a short time ago to today where nearly all drug products under development should include some level of consideration for E&L evaluations. These evaluations often extend beyond the primary packaging container/closure with the primary focus and most in-depth evaluations reserved for products with the highest levels of container-to-drug contact and those that include a direct administration route to the patient, such as inhaled and parenteral products.

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