By Andrew Feilden
The overview of all fabrics - and particularly elastomeric and plastic elements - for the presence of leachable and extractable elements, types a big a part of the submission for approval of a brand new drug approach or clinical gadget. This replace offers a close, cutting-edge evaluate of the choice of innovations, to be had to the analyst, to accomplish a managed extraction research for leachables and extractables, with an outline of the standards to contemplate whilst deciding on the extraction approach. This ebook may be of curiosity to Chemists and R&D managers.
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Additional resources for Update on Undertaking Extractable and Leachable Testing
Y. Kemmochi, K Tsutsumi, A. Arikawa and H. Nakazawa, Journal of Chromatography A, 2002, 943, 2, 295. 21 2 Extraction Techniques Each of the extraction techniques has their own advantages, disadvantages and special considerations for their use. These will be discussed in the following sections as well as potential sources of the equipment. As mentioned in Chapter 1, there is no ideal universal technique. The selection is dependent upon several factors but primarily the matrix, analyte, and solvents used are the most important.
Introduction 9. D. Jenke, Journal of Pharmaceutical Science and Technology, 2002, 56, 6, 332. 10. D. Ball, J. Blanchard, D. Jacobson-Kram, R. McClellan, T. L. M. Vogel, R. M. Nagao, Toxicological Sciences, 2007, 97, 2, 226. 11. L. Norwood, D. Paskiet, M. Ruberto, T. Feinberg, A. Schroeder, G. Poochikian, Q. J. Deng, F. K. M. Nagao, Pharmaceutical Research, 2008, 25, 4, 727. 12. L. M. 1693. 13. G. Willoughby and Scott, Nitrosamines in Rubber, Rapra Technology Limited, Shawbury, Shrewsbury, UK, 1997.
Milling the matrix is recommended to limit the diffusion step inside the matrix and to increase the surface area. This increases the rate of extraction when it is limited by matrix effects. , sodium sulfate) may prevent plugging of the restrictor by ice in the presence of humid matrices. Caution must also be taken when ﬁlling the vessel to ensure a homogeneous bed of material (to prevent channelling) and to take into account possible swelling of the matrix (such as polymers) upon introduction of supercritical CO2.
Update on Undertaking Extractable and Leachable Testing by Andrew Feilden