BRIEFING

 〈11〉 USP Reference Standards. This proposal is based on the version of the chapter official as of November 1, 2020. This new proposal is intended to enable use of digital references standards in compendial tests. It contains revisions to the following sections:

1. Introduction: Expand the scope of the chapter from “materials” to “references for comparison” to be used “in compendial tests,” indicating that USP Reference Standards may be presented either as physical materials or as digital data sets.

2. Establishment Approaches and Value Assignment: Add a paragraph with the establishment approaches to be used for USP digital Reference Standards (USP dRS).

3. USP Reference Standards for USP or NF: Revise the introductory paragraph to include USP dRS in official applications both for quantitative and qualitative determinations. Revise subsection C. under 2. Qualitative determinations from “Digital and Visual” to “Visual.” Revise the subsequent paragraph to indicate the potential for using USP dRS beyond digital images while maintaining the option of USP dRS for visual images to be encoded as digital files.

4. Labeling: Revise to indicate that details of labels affixed to reference standard vials apply to physical USP RS as appropriate.

5. Storage: Revise to indicate that details of storage in this section are applicable to physical USP RS as appropriate.

6. Valid Use Date: Add a paragraph describing the possibility of introducing new versions of established USP dRS and limitations of valid use dates for previous and obsolete versions.

7. Proper Use: Add a paragraph with conditions of proper use for USP dRS, retaining the current text for physical USP RS.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (COE: G.I. Giancaspro)

 Case ID—SUB-266