Webinars, Pharmaceutical

Approaches to Extractables and Leachables in Parenteral Drugs

Extractable and leachable testing is a crucial aspect of ensuring the safety and efficacy of parenteral drugs.

The importance of extractable and leachable testing lies in several key aspects such as Patient Safety, Regulatory Compliance, Product Stability and Efficacy and Quality Control. These tests are critical components of the pharmaceutical development process, particularly for parenteral drugs. E&L tests help identify and quantify potential leachables, assess their impact on patient safety, and ensure the overall quality, stability, and efficacy of the drug product.

Watch the Extractables and Leachables in Parenteral Drugs Webinar Now
Speaker(s): Scott Toth Kyle Chenevert Antonio Scatena
23 Jun 2023

The main objective of extractable and leachable testing is to identify and quantify any potentially harmful or reactive substances that could leach into the parenteral drug and pose a risk to patient safety. These substances can come from various sources, including container closures (e.g., rubber stoppers, plastic materials), delivery systems (e.g., infusion bags, syringes), or manufacturing processes (e.g., residues from cleaning agents, solvents).

The testing process typically involves subjecting the drug container, closure system, or delivery device to controlled extraction conditions to simulate various scenarios it may encounter during storage, transportation, or use. The extracted samples are then analyzed using a variety of analytical testing methods such as gas chromatography (GC), liquid chromatography (LC), mass spectrometry (MS), and spectroscopy, among others.

During this webinar, hosted by Gateway Analytical, an Aptar Pharma company, the speakers extensively discussed the significance of extractable and leachable testing in safeguarding the effectiveness and safety of parenteral drugs. They also explored various facets of study design, such as regulatory norms, best practices, equipment, sample preparation, storage conditions, and interpretation of results specific to products and applications. The speakers also shared a case study that emphasized the collaborative nature of extractables, leachables, and stability studies in conducting a successful E&L study.

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