Extractables and Leachables

Regulatory scrutiny of extractables and leachables (E&L) continues to increase, particularly for higher risk pharmaceutical dosage forms in the areas of inhalation products, injectables, ophthalmic solutions and suspensions, and transdermals. As a result, E&L studies are an essential component of pharmaceutical product development.

Extractables typically arise from packaging components or materials used in dosage form manufacturing. Whereas extractables represent compounds that can be aggressively withdrawn from these materials (potential drug product impurities), leachables are those compounds that migrate into drug products under nominal conditions (actual drug product impurities) and thus must be evaluated with respect to their impact on the safety, quality, and efficacy of the affected drug product.

iuvo personnel have over fifteen years of experience in the E&L field with an extensive track record of designing and executing successful E&L studies in support of NDA, ANDA, and post-market approvals (e.g., packaging changes). Members of the technical leadership at iuvo have been active in direction-setting working group organizations such as the Product Quality Research Institute (PQRI).

iuvo BioScience can provide strategic consulting services (E&L study design); study execution using sensitive, selective analytical techniques such as LC-MS and GC-MS; and toxicological safety assessment of leachables. Studies will be performed according to widely accepted principles such as those found in the PQRI, USP (e.g., <1663> and <1664>), and other standards as applicable.

Tests

Extractables and Leachables