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By Francotte E., Lindner W.

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D. Newton,W. S. Pray, N. G. Popovich, J. Am. Pharm. Assoc. 2004, 44, 211–225. 14 D. M. Perrine, The Chemistry of MindAltering Drugs – History, Pharmacology, and Cultural Context, American Chemical Society, Washington DC, 1996, pp. 44–45. 15 W. O. Foye, Medicinals of Plant Origins: Historical Aspects, in W. O. Foye, T. L. Lemke, D. A. , Lippincott,Williams and Wilkins, USA, 1995, p. 8. See Ref. 8, p. 15. See Ref. 7, p. 3. F. W. A. Sertürner, J. Pharm. 1805, 13, 229–243. F. W. A. Sertürner, Ann. Phys.

It needs to be stressed, however, that it is not only the absolute figure of residual metal that is important but also this level must be put in the context of the daily dose in man. So a case-by-case analysis has to be performed which will say what amounts of a given metal can be tolerated and what is not acceptable. This already very stringent demand can change to an even tougher one if the metal in question shows extremely toxic properties and in effect this excludes the most “evil” ones such as thallium and mercury from ever being used in the production of pharmaceutical products.

Indeed, with an industrial average of about 90 % attrition only 1 out of 10 drugs under development will be launched and, consequently, require the active ingredient to be manufactured at scale [10, 11]. Many contract companies are equally hit by this unfortunate drawback, as they will only be supplying optically pure molecules as long as a particular project stays alive. This is, at least partly, the reason for maintaining a high share of other “competing” approaches seen as easier to handle when process chemists are asked to prepare enantiomerically pure materials.

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