Variables Impacting Silicone Oil Migration and Biologics in Prefilled Syringes.

Prefilled syringes (PFS) as a primary container for parenteral drug products offer significant advantages, such as fast delivery time, ease of self-administration and fewer dosing errors. Despite the benefits that PFS can provide to patients, the silicone oil pre-coated on the glass barrels has shown migration into the drug product, which can impact particle formation and syringe functionality. Health authorities have urged product developers to better understand the susceptibility of drug products to particle formation in PFS due to silicone oil.

Determination of ultra-trace metal-protein interactions in co-formulated monoclonal antibody drug product by SEC-ICP-MS.

Transition metals can be introduced in therapeutic protein drugs at various steps of the manufacturing process (e.g. manufacturing raw materials, formulation, storage), and can cause a variety of modifications on the protein.

A comparative study of sample dissolution techniques and plasma-based instruments for the precise and accurate quantification of REEs in mineral matrices.

The recent commercialisation of inductively coupled plasma tandem mass spectrometric (ICP-MS/MS) instruments has provided analytical chemists with a new tool to properly quantify atomic composition in a variety of matrices with minimal sample preparation. In this article, we report on our assessment of the compatibility of 3 sample preparation techniques (open-vessel acid digestion, microwave digestion and alkaline fusion) for the quantification of rare earth elements (REEs) in mineral matrices. The combination of the high digestion temperatures (1050 °C) and using LiBO as a flux was the most effective strategy for the digestion of all rare earth elements in mineral matrices and was compatible with ICP-MS/MS measurements.

Cloud point extraction of plutonium in environmental matrixes coupled to ICPMS and α spectrometry in highly acidic conditions.

A new cloud point extraction procedure has been developed for the quantification of plutonium(IV) in environmental samples. The separation procedure can be either coupled to inductively coupled plasma mass spectrometry (ICPMS) or α spectrometry for plutonium quantification. The method uses a combination of selective ligand (P,P'-di(2-ethylhexyl) methanediphosphonic acid (H2DEH[MDP])) and micelle shielding by bromine formation to enable quantitative extraction of Pu in highly acidic solutions.

Cloud point extraction of uranium using H₂DEH[MDP] in acidic conditions.

A procedure has been developed for the cloud point extraction (CPE) of uranium (VI) using H2DEH[MDP] (P,P-di(2-ethylhexyl) methanediphosphonic acid) with inductively coupled plasma coupled to mass spectrometry (ICP-MS). The method is based on the modification of the cloud point temperature using cetyl trimethyl ammonium bromide (CTAB) and KI. Optimal conditions of extraction were found using a cross-optimization of every parameter (non-ionic and ionic surfactant concentrations, chelating agent concentration, pH and the extraction, and phase separation temperatures).