The New USP Chapter 41 – Are You Compliant?
By Jennifer Camarda, Sales Specialist, Premium Balances & Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed from Weights and Balances to Balances and it does not reference the minimum sample weight anymore, but rather it defines Repeatability and Accuracy, which specifies the Operating Range of a balance. The operating range is limited to the maximum capacity of the balance and begins at the point at which the balance’s repeatability is less than or equal to 0.10%. The weighing must also be performed using a balance that is calibrated over its operating range.