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Weighing in Pharmaceutical Quality Control according to U.S. Pharmacopeia

USP Chapter 41 Weighing Requirements on Balances in Pharmceutical Quality Control

USP Chapter 41 weighing requirements are mandatory in a Pharmaceutical Quality Control (QC) laboratory, where weighing is a fundamental step in almost every workflow. Typically, weighing of a sample or standard is the first step in the analytical procedure, followed by subsequent dilution and analysis by techniques such as HPLC or qNMR. Any error in the weighing step has the potential to propagate through the whole analytical process, causing inaccuracy in the final result. To avoid this situation, the United States Pharmacopeia (USP) has set stringent requirements for balances which are used for weighing analytes for quantitative measures. These requirements are designed to ensure that any uncertainty in weighing is small or even negligible within the analysis.

This white paper comprehensively explains the requirements of the 2019 versions of USP General Chapters 41 and 1251 and provides advice on how to put these requirements into practice. Weighing according to USP requirements will ensure that a consistently high quality of weighing results is achieved, and is applicable to all pharmaceutical QC activities globally, not just in those operating in the USA.

Ensure that your weighing processes are compliant with the current versions of USP General Chapters 41 and 1251.

Facts, background information, dossiers

  • measurement uncertainty
  • routine tests
  • pharmaceutical industry
  • USP Chapter 41
  • pharmaceutical qual…
  • United States Pharmacopeia

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