Extractable and Leachable Study of Pharmaceutical Packaging Material used to Store Penicillin-V Using ICPMS-2050

User Benefits

- Simultaneous qualitative scanning feature benefits to user in identification of non-targeted elements, supporting the creation of a comprehensive extractable profile. - Proprietary Mini-Torch technology enables stable plasma with higher sensitivity and lower gas consumption (11 L/min). - LabSolutions ICPMS ensures compliance with regulatory norms in spectroscopy products, streamlining data management.

Introduction

Extractable and leachable (E & L) studies are becoming increasingly important in the pharmaceutical industry as it is a mandatory requirement from the FDA during filing of the drug product. The purpose of E & L studies is to identify and evaluate possible toxicological risks. In this, 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.

September 30, 2026 GMT