Application Note: Balances for analytical purposes of the European Pharmacopoeia
6 December 2023
In this Frequently Asked Questions (FAQs) document from Sartorius, the focus is on the implementation of Chapter 2.1.7 'Balances for analytical purposes' of the European Pharmacopoeia (Ph.Eur.), which became effective on January 1, 2022. The chapter specifically addresses requirements for analytical balances used in the pharmaceutical industry. It emphasizes the importance of performance checks between calibrations, specifically focusing on repeatability and sensitivity verification. The FAQs underscore the significance of compliance with Ph.Eur. regulations for companies involved in pharmaceutical production, regardless of their location, if they export products to European member states.