Application Notes: General

Chemical characterization of medical devices, including drug-device combination products, is crucial for ensuring regulatory compliance and patient safety by identifying and quantifying chemicals that may interact with the human body. This paper explores current trends, best practices, and regulatory developments in extractables and leachables (E&L) testing for medical devices.

The diterpenoid, paclitaxel, which was identified as a potent chemotherapy agent for breast and ovarian cancer originates from the Pacific Yew tree. The isolation of paclitaxel from its major impurities is shown with the use of Hamilton’s PRP-1 (5 µm) HPLC column.

With the growing utility of the K vitamin series of molecules, a need appears relevant for both food labeling of constituents and for research based separation of the natural and synthetic compounds of vitamin K. The fast simple method developed by Hamilton Company using the PRP-C18 column allows for simple efficient identification of the whole vitamin series (K2, K3, and K4).

SEC data demonstrates mRNA aggregate analysis for vaccine stability. Optimal separation occurs at 100 mM NaCl and low flow rates, enhancing mRNA production quality.

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How Green is Your HPLC?

The Axcend Focus LC® stands out as an eco-friendly high-performance liquid chromatograph (HPLC) due to its innovative design and sustainable features. This compact system uses significantly less solvent, consuming under 10 mL per week, and produces roughly the same amount of waste. Additionally, its energy consumption is a fraction of that of larger, bench-top LCs. By minimizing solvent use and waste production, the Axcend Focus LC not only reduces operational costs but also aligns with green analytical chemistry principles, making it an environmentally responsible choice for laboratories