Extractable Study of Container Closure Pack Used to Store Oral Drug Product Using Dynamic Headspace Technique

User Benefits

- ASSP and simultaneous Scan/MRM analysis facilitating accurate qualitative identification and quantitation at the same time. - Dynamic headspace enables concentrating the analytes in cold trap with multi-injection count and helps to achieve higher sensitivity over static headspace, especially for trace level quantitation.

Introduction

Extractable and leachable (E & L) studies are becoming increasingly important in the pharmaceutical industry as it is a mandatory requirement from FDA during filing of the drug product. The purpose of E & L studies is to identify and evaluate possible toxicological risks. In this study, the regulatory references aim to identify traces of potential chemical substances. These substances may be harmful to patients due to their toxicity or may impact the activity of the drug product. Hence, to ensure the safety and efficacy of the drug throughout its shelf-life, E & L studies play an important role. Extractables are organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction into an extraction solvent under laboratory conditions. Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product because they have leached into the packaged drug product from a packaging/delivery system, packaging component, or packaging material of construction under normal conditions of storage and use or during accelerated drug product stability studies.

June 3, 2026 GMT