Article | REF: P1382 V3

Minimum Weight Its importance in an analytical or industrial process

Author: Denis LOUVEL

Publication date: May 10, 2020, Review date: November 13, 2020

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5. USP minimum weight

On June 3, 2013, the USP (United States Pharmacopeia) published a revision of General Chapter <41> in the second supplement to USP 36-NF 31.

This revision defines scale control procedures for North American pharmaceutical manufacturers and suppliers, as well as for companies exporting to the USA, and aims to ensure accuracy and eliminate costly over-quality.

General Chapter <41> was revised in June 2019. The changes made do not alter the basic requirements. They officially introduce minimum weighing by explaining how to calculate it on the basis of the deviation of a scale and also how to calculate it when the standard deviation is less than 0.41 d.

5.1 Extracts from article <41>

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