SC IV H. Materials Used in Chromatographic Tests

Introduction

In pharmacopoeial monographs elaborated by the British Pharmacopoeia Commission, the brand name of a TLC plate, a chromatographic column or column packing material that has been found to be suitable for the purpose is usually included in the text. The inclusion of such information does not imply that a different but equivalent commercial brand may not be used.

In monographs from the European Pharmacopoeia, references to commercial sources of, inter alia, TLC plates and chromatographic columns are not given. However, records of the materials used during development of the monograph are included when the draft monograph is published for comment in Pharmeuropa.

Liquid chromatographic tests

Defining an appropriate chromatographic system for liquid chromatographic tests is complicated by the existence of numerous variants of stationary phases, particularly amongst the chemically-bonded reverse phase materials for which not only brand to brand, but also occasionally batch to batch variations occur that can influence a separation. To assist analysts in the choice of column, the European Pharmacopoeia Commission has prepared a table of the characteristics of different types of octadecylsilyl stationary phases. The Table was published in the 3rd edition of the Technical Guide to the Elaboration of Monographs [special issue of Pharmeuropa; December 1999] and is reproduced below. The Table lists columns that have been widely used in the development of pharmacopoeial tests, but does not imply that a different but equivalent column cannot be used.