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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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USP minimum weight
Minimum weight according to European Pharmacopoeia PE
Bibliography
- (1) - SFSTP - Quand la pesée minimale prend des proportions énormes ou la pesée minimale et ses conséquences. - Revue STP Pharma Pratiques, volume 16, n° 1, janvier/février 2006.
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United States Pharmacopeia USP http://www.usp.org
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