Revision of USP <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples
Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
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In the Pharmacopeial Forum, PF 47(4), a proposal of USP Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples has been published for comments.
The proposal is based on the version of the monograph official as of March 1, 2019, but the chapter was completely revised.
According to the USP, the new chapter "is presented with a general approach that provides a process for evaluating the number of observed results that fall outside defined limits. The approach can also be used for tests that are inherently pass/fail in nature. It should be noted that the procedure described in this chapter is not intended as a batch release test for content uniformity nor as a replacement of or alternative to Uniformity of Dosage Units <905> for compendial purposes."Comments on the chapter can be submitted from now on. The comment deadline is September 30, 2021.
The draft can be viewed here. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)
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