The General Chapters-Chemical Analysis Expert Committee (GC-CA EC) has been evaluating the impact of removing references to element-specific chapters and standalone element-specific tests (tests for which procedures are described in a monograph) from USP–NF monographs, including excipient monographs, as the result of the implementation of USP General Chapters Elemental Impurities—Limits and Elemental Impurities—Procedures. In the Stimuli article titled “Future of Element-Specific Chapters in the USP–NF,” published in Pharmacopeial Forum 42(4) [Jul–Aug 2016], the GC-CA EC stated that implementation of renders the element - specific chapters and limit tests in monographs as unnecessary unless there is a known quality- or safety-related reason to maintain the specific elemental impurity limit(s) currently in place for selected components (drug substances or excipients). In response to the GC-CA EC’s effort to determine the future of element-specific chapters in USP–NF, the Excipient Expert Committees (Excipient ECs) in collaboration with Element-Specific General Chapters Joint Subcommittee have developed a path forward (draft Roadmap) to address the use of procedures described in element-specific chapters and standalone element-specific tests for elemental impurities (EIs) in excipient monographs. The Excipient ECs considered the European Pharmacopoeia Commission’s policy on EIs as a possible basis for developing the draft Roadmap. The purposes of the draft Roadmap are to inform excipient stakeholders about the USP strategy for addressing element-specific tests in excipient monographs and to engage excipient stakeholders to assist USP with development of the final Roadmap. Stakeholders have the opportunity to provide feedback on a proposed approach for addressing EIs in excipient monographs, identify excipients for which EI tests are necessary because of their impact on an excipient’s quality, and provide scientific information on typical levels of EIs and methodologies used. The Excipient ECs and USP staff used a multistep approach to create a draft Roadmap that addresses element-specific tests in excipient monographs. This approach includes: identification of USP–NF excipient monographs that have tests for EIs; grouping monographs based on common elements, references to an element-specific chapter, and instrumental or wet chemistry techniques for standalone EI tests; prioritization of monographs; and characterization of monographs for deletion or revision of EI tests based on the origin of an excipient.
This draft Roadmap focuses only on monographs that reference seven element-specific chapters and/or have corresponding standalone EI test. These chapters are: Aluminum (not part of ), Arsenic, Iron (not part of ), Lead, Mercury, Selenium, Zinc Determination (not part of ). It also describes the difference in the way the tests for elements that are not part of are treated. Tests for the EIs other than the seven listed above are outside the scope of the draft Roadmap and are scheduled for future consideration. The monographs containing these EI tests have no prioritization level identified. The draft Roadmap provides a clear understanding of the proposed strategy for addressing element-specific tests in excipient monographs and creates a basis for recommendations on the future of the element-specific chapters for excipients.
Understand the driver behind and the basis for work on addressing tests for elemental impurities (EIs) in USP–NF excipient monographs
Evaluate the multistep approach for creating a Roadmap that addresses element-specific tests in excipient monographs
Review the Roadmap that identifies monographs in which the Excipient Expert Committees propose deleting or revising the element-specific tests
Recommend changes to the proposed multistep approach and/or to the prioritization and characterization of excipient monographs