In situ degradation: a new concept for system suitability tests in monographs of the European Pharmacopoeia

Monographs of the European Pharmacopoeia describe in the LC-test for relate d substances usually a system suitability test in order to ensure the adequ ate separation of impurities. Since the reference substances required are o ften not available a recent approach to avoid this problem is the generatio n of the required impurity by 'in situ degradation' of the active principle . This paper describes some typical applications of this technique as well as recent examples, such as the controlled degradation of cefalotin sodium, imipenem and spiramycin. (C) 1998 Elsevier Science B.V. All rights reserve d.