Performance Test According To Chapter <41> Of The United States Pharmacopeia (USP)

Chapter <41> of the United States Pharmacopeia (USP) describes specific criteria for balances used for the "accurate sample weighing" of materials and emphasizes the criticality of weighing samples accurately in pharmaceutical analytical processes. The objective of Chapter <41> of the USP is to ensure that the error introduced by the weighing application for "accurately weighed" material is reduced to an acceptable or negligible level, thereby ensuring that the effect on the total error remains manageable.

To be compliant with the requirements of Chapter <41> of the USP the balances must be calibrated over the entire working range. In addition, they must meet the tolerance requirements for testing repeatability and accuracy during performance tests.

This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the USP.