Get Analysis of Drug Impurities (Sheffield Analytical Chemistry PDF

By Richard J. Smith, Michael L. Webb

ISBN-10: 1405133589

ISBN-13: 9781405133586

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Additional info for Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)

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Chromatogr. A, 2001, 918, 319–324. 13. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q7A: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2000. 14. G. Xue, A. D. Bendick, R. Chen and S. S. Sekulic, J. Chromatogr. A, 2004, 1050, 159–171. 15. R. Otero, G. Carrera, J. F. Dulsat, J. L. Fábregas and J. Claramunt, J. Chromatogr. A, 2004, 1057, 193–201. 20 ANALYSIS OF DRUG IMPURITIES 16. K. J. Mulligan, T.

5 Conclusions By understanding the manufacturing process and the stability of the drug substance, whether from synthetic, natural, or recombinant sources, the chemist is able to identify, control, and measure the impurities, and so the quality of the drug substance and reproducibility from production batch to batch are maintained. Disclaimer The views expressed above are the personal views of the authors. S. government. References 1. USPharmacopeia 29/National Formulary 24, 1086, Rockville, MD, 2006, p.

It has been shown in a number of instances that under identical conditions the reaction rates of amorphous forms are greater than in crystalline forms of the same drug [21]. Generally, water has a destabilising effect in the majority of cases, for example, deamidation, hydrolysis or oxidation [27]. In summary, there are at least four ways in which residual moisture in the amorphous state can impact on chemical reactivity. First, as a direct interaction with the drug, for example, in various hydrolytic reactions.

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Analysis of Drug Impurities (Sheffield Analytical Chemistry Series) by Richard J. Smith, Michael L. Webb


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