ABSTRACT
In many cases the ingredients used in a pharmaceutical product are purchased from third parties. With some materials there are pharmacopoeial monographs on which the purchaser can rely when agreeing a purchasing specification with the vendor of the material. In some cases the pharmacopoeial monograph may not be adequate. Examples include where the route of administration is different from that for which the pharmacopoeial specification was developed or where the monograph does not contain sufficiently specific impurity controls to ensure adequate limitation of potentially toxic impurities arising from a modified or different synthetic route. In other cases there will be no pharmacopoeial monograph at all.
