Revision of the General USP Chapter <1010>
Recommendation
1/2 July 2025
Berlin, Germany
Development / Quality Control and in vivo Relevance
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In the Pharmacopoeial Forum 40(3) the In-process-revision of the general USP Chapter <1010> - Analytical Data - Interpretation and Treatment - was announced. This revision was suggested due to the proposals the USP received for this capter.
The part on the use of USP reference substances now also describes more detailed the handling of secondary standards which can be traced back to the USP reference standards.
Further, in the entire document the term "method" was replaced by the term "procedure" as far as the description of analytical testing is concerned. This was done in adapting the document to today's USP terminology.
In addition there will be a new Appendix F in which a new statistical test is described for the evaluation of the equivalence of analytical procedures.
Please see the chapter <1010> - Analytical Data - Interpretation and Treatment for further information.
Source: USP - http://www.usp.org
