Be Compliant with "Balances for Analytical Purposes"

Chapter 2.1.7 of the Ph.Eur. was published in July, 2021 and became effective on the 1st of January, 2022. It is mandatory for any analytical weighing procedure described in a Ph.Eur. monograph.

The Ph.Eur. is published by the European Directorate for the Quality of Medicines & Health care (EDQM) and is “a single reference work for the quality control of medicines in the signatory states of the Convention on its elaboration.”

The Ph.Eur. is the legally binding reference for all pharma-ceutical companies placing pharmaceutical products in the market of European member states. This means it is not only relevant for European pharmaceutical companies but for any producers of medicines and | or substances for pharmaceutical use who export into the European market.

This Compliance Guide explains:

• the meaning of "analytical purposes"

• the requirements of chapter 2.1.7 concering the calibration of a balance

• how the Cubis® II laboratory balance from Sartorius supports compliance with chapter 2.1.7

• the main differences between the Ph.Eur. Chapter 2.1.7 and United States Pharmacopeia (USP) Chapter <41>

• the requirements on repeatability and sensitivity