- What is the difference between the new reference standard (1222818 USP Dissolution Performance Verification Standard – Prednisone RS) and the current reference standard (1559505 USP Prednisone Tablets)? – The new standard will be more sensitive to operational and mechanical variables of instrument setup, less sensitive to media degassing, and more reproducible. The packaging configuration has been changed to include additional protection against moisture. This will provide users with more confidence in dissolution results obtained from the new performance verification standard.
- Why is a new standard being released? – The release of the new standard is a part of USP’s commitment to continuous enhancement of our products and services. The introduction of the new standard and the revision of <711> are being recommended based on discussions with, and feedback from, various USP stakeholders.
- Will the new standard be priced differently? – USP is in the process of recommending a price for the new standard. When the new standard is launched, the price will be available on the USP Store: https://store.usp.org/
- Is the Valid Use Date (VUD) for the new standard going to be longer than for the existing standard? – At this time, USP does not anticipate a change to the VUD as compared to the current standard. Additional data will be collected on the initial lot to explore the possibility of extending the VUD for future lots.
- Will the current standard be discontinued? – The proposed revision to <711> will allow for the use of the current standard (1559505 Prednisone Tablets) or the new standard (1222818 Dissolution Performance Verification Standard – Prednisone) to provide users flexibility of using either product and to allow time to transition from the current standard to the new standard. USP plans to discontinue the current standard (1559505 Prednisone Tablets) in July 2024, however the exact timing may change.
- What studies would a user need to conduct if shifting from the current standard to the new standard? – USP cannot comment on what studies need to be performed internally by specific users outside of the requirements for <711>.
- What advantages does the new standard present over mechanical calibration? – Please refer to USP’s PVT information page.
- What stakeholder engagement tools does USP plan to use when the new standard becomes available? – USP will have a number of informational tools including webinar(s), a white paper, video(s), and more covering the new DPVS-Prednisone product prior to its release. Additional information will be provided when available.
Updated January 28, 2022