A key step in quantitative NMR (qNMR) testing is the weighing of standards and samples, as the accuracy of qNMR is greatly influenced by the precision of the weighing process. The USP General Chapter <761> draft revision introduces the calculation of uncertainty in the development and validation of qNMR methods. To prevent the use of balances from becoming a significant factor affecting the measurement uncertainty of the entire qNMR analysis, this lecture will invite Dr. Klaus Fritsch from Mettler-Toledo to introduce the basics of determining instrument measurement uncertainty, the importance of balance calibration, concepts such as minimum weighing quantity, and how to integrate balances into lifecycle management. The aim is to establish good weighing practices to ensure consistency in weighing accuracy throughout the entire product lifecycle.

Subject area:
Drug Products & APIs

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical scientist
QA/QC analysts
R&D staff
Regulatory staff
Contract research organizations
Contract manufacturing organizations