- Is the new reference standard (USP Dissolution Performance Verification Standard- Prednisone RS catalog #1222818) available for sale?
Yes, please refer to the product page on the USP Store for up-to-date information on the release of the new reference standard.The associated revisions to General Chapter <711>Dissolution are targeted to become official on 01-May-2023, at which time the new reference standard will be the only reference standard which can be used to meet the requirements of <711> Dissolution. The release of the new reference standard prior to the General chapter <711> Dissolution targeted official date would provide an opportunity for users to update internal documents and obtain experience with the new reference standard.
- Why was a new reference standard released?
The release of the new USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818 is a part of USP's commitment to continuous enhancement of our products and services. The introduction of this new reference standard and the associated revisions to General Chapter <711>Dissolution are being recommended based on discussions with, and feedback from, various USP stakeholders. - What is the difference between the new reference standard (USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818) and the current reference standard (USP Prednisone Tablets RS catalog #1559505)?
Based on the internal USP studies that have been performed, the new reference standard is considered more sensitive to operational and mechanical variables of instrument setup, less sensitive to media degassing, and more reproducible. The packaging configuration has also been changed. Each blister pack of 6 tablets is packaged in an aluminum sachet to provide additional protection against moisture. - Will the Valid Use Date (VUD) for each lot of the new reference standard continue to be provided on the USP Certificate?
Yes, the Valid Use Date (VUD) will be included on the USP Certificate for the new reference standard (USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818). - Will USP Prednisone Tablets RS catalog #1559505 be discontinued?
Yes, the current reference standard (USP Prednisone Tablets RS catalog #1559505) will be discontinued on or about 28-Apr-2023 in anticipation of the associated revisions to General Chapter <711> Dissolution becoming official. The target official date for the proposed revisions is 01-May-2023. These revisions include the replacement of the USP Prednisone Tablets RS with the USP Dissolution Performance Verification Standard – Prednisone RS. USP has released Lot R154P0, which will be the last lot of the USP Prednisone Tablets RS and has an assigned Valid Use Date (VUD) of 31-July-2023. - Can I still use the current reference standard (USP Prednisone Tablets RS catalog #1559505) after the official date of the revised documentary standard?
No, Lot R154P0 cannot be used to meet the requirements of General Chapter <711> Dissolution after the revisions are official (Target Official Date: 01-May-2023). - Can I use the new reference standard (USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818) to meet the requirements of the currently official version of General Chapter <711> Dissolution?
No, USP Dissolution Performance Verification Standard – Prednisone RS (catalog #1222818) cannot be used to meet the requirements of General Chapter <711> Dissolution where the use of USP Prednisone Tablets RS (catalog #1559505) is specified. It has been provided prior to the official date of the <711> revisions only to ensure users have sufficient time to prepare for compliance by the official date (Target Official Date: 01-May-2023). Early adoption will not be allowed (see next question). - Will the revisions to General Chapter <711> Dissolution be eligible for early adoption?
The new standard (USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818) has been made available for purchase before the revision to General Chapter <711> Dissolution is targeted to become official in order to allow users to update internal documents and obtain experience with the new reference standard. However, the <711> Dissolution revisions is not eligible for Early Adoption (refer to General Notices 3.10). The new reference standard (USP Dissolution Performance Verification Standard- Prednisone RS catalog #1222818) is a unique formulation and has a different dissolution profile compared to the USP Prednisone Tablets RS (catalog #1559505). USP is not allowing early adoption in order to minimize ambiguity on compendial compliance. -
Is Performance Verification Testing (PVT) performed before the revision to General Chapter <711> Dissolution still valid after the revision becomes official?
The <711> Dissolution revision will not require customers to reevaluate an instrument that underwent Performance Verification Testing (PVT) prior to the official date. <711> Dissolution indicates that the apparatus suitability test must be performed “periodically” (without indication of a definitive time-period). USP recommends six-month intervals in the PVT Toolkit: https://www.usp.org/reference-standards/dissolution.pvt. - What advantages does the use of the USP Performance Verification Test (PVT) present over mechanical calibration?
PVT verifies that the user is getting accurate dissolution results to ensure patient safety and avoid costly recalls due to quality issues. Mechanical qualification alone does not provide sufficient evidence that the apparatus is performing satisfactorily. PVT assesses the operation of the whole assembly, to verify that the different components are working together properly. Both mechanical and PVT are necessary to ensure that a dissolution instrument is fully qualified. For more information and benefits of PVT, please refer to the following while paper on dissolution tester qualifications: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/usp-pvt-dissolution-test.pdf - What stakeholder engagement tools does USP plan to use when the revisions to General Chapter <711> Dissolution become official?
USP will have a number of informational tools, including but not limited to a product factsheet, webpage, video(s), webinar(s), and a white paper, available to users regarding the new reference standard and General Chapter <711> revisions. Additional information will be provided here when available. - Does using tweezers affect the integrity of the tablets? – USP Dissolution Performance Verification Standard - Prednisone RS (catalog #1222818) is stronger than USP Prednisone Tablets RS (catalog #1559505). Due to the changes in size and formulation of the new reference standard, the new tablets require a significantly higher tablet breaking force compared to the current product. We have not observed any issues with crushing or scratching the tablet surface when using metal forceps to handle the tablets in our lab. Of course, as with any analytical method, best practices for handling and testing a product are likely to be product-specific and can always be improved. Please refer to the following video for additional information on DPVS – Prednisone packaging and handling: https://www.youtube.com/watch?v=ou_qjeXXsVg
Updated February 22, 2023