Pharmacopoeial Reference Standards for Quantitative Use

Stefan Almeling, Head of Division Analytical Chemistry, Laboratory Department, European Directorate for the Quality of Medicines & Healthcare (EDQM), Strasbourg, France

The presentation will focus on the establishment of Ph.Eur. Reference standards (RS) for quantitative use. It will deal with the establishment process of different types of quantitative standards, i.e. standards used for content determination of the active pharmaceutical ingredient, external standards used for the quantification of impurities in the related substances test, and reference materials used for equipment verification. Besides the presentation of the general establishment process, special emphasis will be put on the importance of orthogonal analytical techniques for the characterization of a reference standards. Eventually, questions concerning the uncertainty of the assigned content value of a quantitative standard will be discussed.