USP: Comments possible on the Topic "Balances <41>"

The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now published on the USP Pharmacopeial Forum website for comments. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.

In addition to formal changes, adjustments and additions were mainly made in the following areas:

  • An addition to the connection between the calibration and the performance checks with regard to the life cycle approach to ensure fitness for purpose, 
  • The risk-based approach in relation to the frequency of calibration and performance checks, 
  • A new section on calibration explaining the issues of frequency and uncertainty, 
  • Explanatory information on the topic "repeatability test", 
  • With regard to the topic of standard deviation, the minimum weight was aligned with the information in the chapter "Weighing on an Analytical Balance <1251>" and the European Pharmacopoeia (Ph. Eur.). Example calculations have been added,  
  • An explanatory note to clearly separate the minimum weight from the smallest net weight, 
  • Explanatory notes to explain that accuracy was ensured during performance testing and calibration, taking into account the uncertainty of the test weights, and 
  • Adding further references in the texts.

You can view and comment on the draft chapter "Balances <41>" after a one-time registration on the Pharmacopeial Forum website.

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