Extractable Study of Pharmaceutical Packaging and Delivery System Used for Ophthalmic Drug Product

User Benefits

- ASSP™ and simultaneous Scan/MRM analysis facilitates accurate qualitative identification and quantitation at trace levels - UFsweeper™ allows quicker ion transmission in the collision cell suppressing crosstalk & enables faster MRM analysis - Thermal Desorption (TD) System offers a direct sampling feature that significantly reduces extraction time and prevents the loss of VOCs

Introduction

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

8 de octubre de 2024 GMT