![]() This means if the determined standard deviation from the replicate test is less than the 0.41d value then the 0.41d value will need to be used in the assessment calculation. There is also now a “standard deviation floor” of 0.41d (d being the scale interval or the readability of the unit). ![]() The denominator in the calculation is now stated as the “Desired Minimum Sample Weight”, not the weight applied as previously stated. (2 × SD) ÷ Desired Minimum Sample Weight ≤ 0.10% The resulting standard deviation is to be used in the following calculation: The Repeatability test consists of 10 replicate weighings. This can be the tolerance of the nominal value of the weight or it can be the uncertainty of measurement for the weight when applying the actual weight value from the certificate. The Accuracy requirement is applicable between 5% and 100%.Ĭalibration weights being used in the Accuracy check must have an accuracy of NMT 1/3 of the balance tolerance for that respective test point. There are two required tests in Chapter 41, Accuracy and Repeatability. ![]() Here is a quick reference on the important aspects and updates:Ĭhapter 41 is a REQUIREMENT for QC analysis measurements. USP Chapter 41 has updated their testing requirements to determine the suitability of balances.
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