New Pharmeuropa Bio & Scientific Notes Article on Weighing according to the European Pharmacopoeia

In the Pharmeuropa Bio & Scientific Notes, a free online journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM), a new scientific article entitled "Weighing according to the European Pharmacopoeia: general considerations and new general chapter 2.1.7. Balances for analytical purposes" was published.

Background

In the European Pharmacopoeia (Ph. Eur.) Supplement 10.6, published in July 2021, a new general chapter 2.1.7 Balances for Analytical Purposes was included. The chapter became legally binding on 1 April 2022. According to the EDQM "this new general chapter complements existing guidelines for the use and qualification of balances published elsewhere."

Content of the Article

The nine-page article published in Pharmeuropa Bio & Scientific Notes was written by K. Fritsch, C. Saal, and B. Spieldenner. It is divided into the following sections:

• Introduction
• Quantities in the Ph. Eur.
• Equipment performance
• Summary/Conclusion
• References

According to the information given in the introduction, the intention of the article "is to explain in detail the approach taken in the newly published general chapter. This article provides advice on how to put these requirements into practice to ensure consistently high-quality weighing results and compliance with the Ph. Eur.".

The article first provides a short review of the Ph. Eur. requirements applying to quantities, whereby particular attention is paid to the information given in the Generel Notices.

After that, the section in General Chapter 2.1.7 on Equipment Performance is summarized and discussed in detail. Calibration of balances, performance check to assess the precision of the balance as well as well as performance check to assess the accuracy of the balance are covered.

The authors conclude that "accuracy and precision are critical to any quality-related weighing operation. The Ph. Eur. has defined clear requirements in its new general chapter 2.1.7, and compliance with these should ensure that weighing does not significantly contribute to the overall uncertainty of an analysis."

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