Oct 9, 2018 – MSDG Meeting

Large molecules and high resolution mass spectrometers are getting all the press, but quantitative analysis of small molecules using Triple Quadrupole Mass Spectrometers in support of TK, PK and PD studies, particularly in Drug Discovery is still in high demand. To address the increasing complexity of drug targets, medicinal chemistry is taking innovative approaches in drug design, which translates into greater challenges for the Bioanalyst.

We present LC-MS/MS assay development for measuring exposures of parent compounds and their stereoisomeric metabolites as well assays for highly polar, poorly ionized compounds. And, of course, high assay sensitivity is needed in the analysis of biological matrices alcoholism such as plasma, urine, whole blood, tumor, spleen and lymph nodes.

Extractables from packaging materials are a concern to manufacturers and suppliers of containers for the regulated food and pharmaceutical industries. The food industry is most regulated in European Union where recent regulations require testing and characterization of non-intentionally added substances in food-contact materials. Pharmaceutical industry is regulated in both the United States and Europe where extractable and leachable studies are mandatory to receive an approval for drug marketing. Due to these regulations packaging material manufacturers are motivated to control and monitor their product to ensure that no potential risk exists from extractable and leachable material.

The challenge with the compounds observed in the extraction studies is their identification. The manufacturers rarely provide a complete list of all the additives in polymers used for packaging. The original ingredients can degrade or undergo chemical changes during the manufacturing process. Also there may be contaminants that the manufacturer is not even aware of.

LetM-^Rs review how HRMS is applied for testing migration or leaching from these items to meet the regulatory requirements and to protect patients and consumers.