Extractable & Leachable Studies
Leachable materials may originate from pharmaceutical container closure systems, process equipment, medical device packaging, and migrate to contaminate products. Extractable and Leachable (E/L) studies to identify and quantify these compounds, ensuring the quality and effectiveness of the drug product. A full-service extractable and leachable testing program also helps you to fulfil the regulatory requirements.
Evaluating the impact of extractable and leachable compounds on safety of the drug product interaction is of utmost importance to protect the patient safety and comply with regulations.