Risk-Based Extraction and Leaching Studies for Injectable Drug Products: Addressing Process Impurities, Nitrosamine Formation, and Syringe Siliconization Effects: Poster Presented at PDA Week 2026.

The safety and quality of injectable drug products are influenced not only by formulation and manufacturing processes but also by the container closure system, including prefilled syringes and vials. Extractables and leachables (E&L) from elastomers, plastics, adhesives, and coatings can migrate into formulations, affecting safety, efficacy, and compliance. In parallel, residual process impurities may compromise stability during long-term storage. Emerging concerns highlight additional risks. Formation of nitrosamine compounds arising from drug-excipient or impurity interactions has raised global regulatory scrutiny due to their potential carcinogenicity. Likewise, siliconization of prefilled syringes while essential for functionality can alter glide forces and introduce silicone oil droplets, with implications for both product performance and patient safety. These evolving challenges underscore the importance of a holistic risk-based E&L framework.This presentation will discuss strategies aligned with USP < 1663>, < 1664>, ICH, and EMA guidance with emphasis on: Characterizing and monitoring E&L under stability conditionsEvaluating nitrosamine formation and syringe siliconization risksApplying robust analytical and mechanical testing methodologiesIntegrating findings into lifecycle and regulatory strategiesHolistic E&L evaluations incorporating chemical, mechanical, and toxicological perspectives strengthen product quality, patient safety, and regulatory confidence while supporting innovation in injectable drug delivery systems.