NMR Spectroscopy in the European Regulatory Dossier

The development of NMR spectroscopy since its inception in the 1950s has been remarkable in demonstrating its power and versatility in the fields of chemistry, biochemistry, biology and medicine, as exemplified in other chapters of this book. The pharmaceutical industry has employed various aspects of the technique during development of drug substances and new medicinal products and thus NMR spectroscopy has an established role in the regulation of medicinal products which is described in this chapter. 

Directive 75/318/EEC indicates that the dossier should be presented in four parts. Part I taking the form of a summary of the information presented. Part II relates to the quali of the product and gives details of its chemical, pharmaceutical and biological testing. In cases where the active ingredient is made by a manufacturer other than the applicant or product manufacturer, some of the information required in Part II may be presented in a 

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