The revised chapter details a relatively demanding balance assessment, outlining accuracy and repeatability tests for calibrated balances used to weigh analytes for quantitative measures. The new requirements of General Chapter 41 are mandatory. METTLER TOLEDO’s Global Weighing Standard: Good Weighing Practice™ (GWP®) can help consumers put the new standards into practice in a structured and effective way. The revisions to both chapters in the Second Supplement to USP 36-NF 31 aim to help US pharmaceutical manufacturers and suppliers ensure accuracy and eliminate costly over-testing. In addition, they frequently commented that General Chapter 1251 (“Weighing on an Analytical Balance”) no longer represented state-of-the-art weighing practices. In addition, METTLER TOLEDO is also offering a wealth of information on their website including a free white paper and a video as well as the opportunity to register for an easy e-learning course.įor a long time balance users and manufacturers argued that balance assessment as per USP’s General Chapter 41 (“Balances”) was unclear and difficult to comply with. With the revised chapters becoming official on 1st December, 2013, METTLER TOLEDO is providing a free on-demand webinar to explain how balance quality management will be affected, focusing on the determination of minimum weight and execution of routine testing.
The new revisions define modified balance test procedures for the US pharmaceutical industry and also apply to companies exporting to the US. With just six months to comply, METTLER TOLEDO’s global weighing standard, GWP®, can help pharmaceutical manufacturers and suppliers to meet the new requirements.
On the 3rd June, 2013, United States Pharmacopeia (USP) published the revised mandatory Chapter 41 on balances as well as new updates to the advisory Chapter 1251. METTLER TOLEDO’s unique GWP® Verification service helps companies comply with the new revisions
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