SCHOTT Pharma Services: Comparative Extractable Studies for Injectables and medical devices aligned with USP <1663> and ISO 10993 Guidelines

The whitepaper provides an in-depth analysis of regulatory frameworks and methodologies for extractables and leachables (E&L) studies. Authored by experts at SCHOTT Pharma Services, it compares study designs based on USP <1663> and ISO 10993 guidelines, emphasizing chemical characterization and risk management for drug packaging and medical devices. Through case studies, the paper highlights analytical techniques and systematic procedures to ensure safety and regulatory compliance in pharmaceutical packaging and delivery systems.

Register for the SCHOTT ID and get access to SCHOTT Pharma exclusive content:

SCHOTT ID is your central key to valuable information and features related to our products and applications. Whether you are an interested party, customer, or partner, you can benefit from simplified access to extended content, practical tools, and digital offerings alongside our range of products.