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4. Conclusion
Solvents, including water, are an integral part of the drug production process. Given their potentially negative impact on pharmaceutical properties (toxicity, manufacturability, stability), their residual content must be kept as low as possible. Finding them is an essential part of any registration dossier for marketing authorization. This article should enable readers to implement an effective methodology that is accepted in all countries.
We would like to thank Franck Bourbon, Anne Chambaudy, Geneviève Delerm-Germès, Jean-Pierre Guimbard, Juliette de Miras, Florence Persée, Guy Taulelle and Marlène Vallerugo for their invaluable help in preparing this article.
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Bibliography
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Regulations
European Pharmacopoeia http://www.Pheur.org
HMC USP https://hmc.usp.org
EDQM http://www.edqm.eu
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