On the sequential separation and quantification of 237Np, 241Am, thorium, plutonium, and uranium isotopes in environmental and urine samples.

The implementation of the one-pass-through separation technique using two stacked chromatography columns of TEVA - TRU resins for the separation of 237Np, 241Am, thorium, plutonium and uranium from environmental and urine samples was investigated. The sequential separation technique proved to be successful and gave similar results to those obtained when using individual separations. The analysis time was considerably improved. The amount of chemical waste was also reduced by 50% and the use of HClO4 was avoided. The technique of ICP-MS was also investigated as a complementary technique to alpha-spectrometry.

Determination of elemental impurities in leachate solutions from syringes using sector field ICP-mass spectrometry.

Prefilled syringes are of increasing importance on the drug product market. Drug products supplied in prefilled syringes have to comply with guidelines on elemental impurity limit concentrations. Elemental impurities may be introduced through any reagents or catalysts used or any product contact surface. This work addresses the determination of elemental impurities leaching from three types of glass syringe container-closure systems supplied by two leading manufacturers. Leachate solutions of every type of syringe were analyzed for Na, Al, Si, W and the 16 elements listed in draft USP chapter 232, which were selected on grounds of toxicity. Elemental impurity concentrations were determined using sector field ICP-mass spectrometry. Significant concentrations of Na and Si were found in all leachate solutions, up to 1200 and 4500µgL(-1), respectively. In addition, also Al, As and W were leached out of syringes from one manufacturer in variable amounts, giving rise to average concentrations (std. dev., n=6) of 400 (120), 0.55 (0.08) and 230 (220)µgL(-1), respectively. So far, no exceeding of limit concentrations was observed.

Ecotoxicity and uptake of polymer coated gold nanoparticles.

Bioconjugated gold nanoparticles (Au NPs) are a promising tool for pharmaceutical applications. However, the ecotoxicity of these types of NPs has hardly been studied. We investigated the ecotoxicity and uptake of 4-5 nm Au NPs to which two types of polymer coatings were attached. One coating was an amphiphilic polymer only and the other an amphiphilic coating to which 10 kDa polyethylene glycol chains were attached. In both 72 h algal growth inhibition tests with the alga Pseudokirchneriella subcapitata and in 24 h resazurin cytotoxicity tests with the rainbow trout gill cell line RTGill-W1, the pegylated Au NPs were found less toxic compared to the amphiphilic coated particles. No uptake or direct interaction between particles and algal cells was observed. However, uptake/adsorption in fish gill cells reached up to >10(6) particles/cell after 1 h and particles were eliminated for ≥96% after 24 h depuration. Both particle types were found within membrane enclosed vesicles in the cytoplasm of RTgill-W1 cells.