Performance Test According To Chapter 2.1.7 Of The European Pharmacopoeia

Chapter 2.1.7. of the European Pharmacopoeia (Ph. Eur.) describes specific principles for the use of balances used in analytical procedures. All measurements that are carried out as part of tests to determine compliance with a monograph must be carried out in accordance with the principles outlined in Chapter 2.1.7. of the Ph. Eur. The objective is to ensure that the error introduced by the weighing application is reduced to an acceptable or negligible level.

To meet the requirements of Chapter 2.1.7. of the Ph. Eur. weighing results must be traceable to a SI unit, which among other things means that the respective balance must be calibrated with associated uncertainties. In addition, balances must meet the tolerance requirements of repeatability and sensitivity during performance tests.

This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the Ph. Eur.