Choice of analytical assay methods from a pharmacopoeial point of view

The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for use by healthcare professionals and others concerned with the quality of medicines. Such standards are to be appropriate as a basis for the safe use of medicines by patients and consumers. Their existence:

• facilitates the free movement of medicinal products in Europe;

• ensures the quality of medicinal products and their components imported into or exported from Europe.

European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:

• regulatory authorities;

• those engaged in the control of quality of medicinal products and their consitutents;

• manufacturers of starting materials and medicinal products.

In this context, the author will provide background information on which grounds the choice of assay methods is made by the groups of experts and the European Pharmacopeia Commission. In the particular he will address the advantages and difficulties linked to the introduction of hyphenated assay techniques to monographs and the potential implications for the users of the monographs.