The USP have created a new tablet standard for the Performance Verification Testing (PVT) of dissolution instrumentation, to replace the existing prednisone tablet standard (USP Cat. No. 1559505) . Called Dissolution Performance Verification Standard – Prednisone (DPVS Prednisone, USP Cat. No. 1222818), this new standard has been designed to provide greater reassurance in the performance qualification of dissolution Apparatus 1 (Basket) and Apparatus 2 (Paddle).
Whilst still based on prednisone, this new standard has the following features and improvements:
Stable throughout its shelf-life, hence lower tablet-to-tablet variability.
Sensitive to critical changes in the setup of both apparatus 1 and 2.
Ball-shape of the tablet to ensure consistent positioning of the tablet in apparatus 1 and 2.
Less sensitive to media degassing, thus providing better sensitivity to other critical operational and setup parameters.
New easy-to-open blister packaging with push-through design and additional sachet packaging to protect against environmental moisture.
These features are designed to improve accuracy and sensitivity, delivering more consistent results.
DPVS Prednisone has now been released, but will not replace the current prednisone tablet standard until it is made official in the new revision of the USP dissolution chapter, chapter <711>. The current target date for this to be made official, is 1st May 2023. Once it is made official, DPVS Prednisone will replace the current prednisone standard, making DPVS Prednisone the only useable tablet standard for Dissolution Apparatus 1 and Dissolution Apparatus 2 performance qualification. The new DPVS Prednisone comes with new GM and %CV limits, detailed in the attached certificate.
The prednisone powder reference material (USP Cat. No. 1559006) used to make the working standard for the dissolution samples to be analysed against will remain unchanged, as will the dissolution test structure, methodology (there are some minor revisions to the wording), pricing and price structure. All PM and OQ/MQ activities also remain unchanged.
The USP has also created a webpage for this at the following URL which has a short Q&A video:
To ensure that the rollout of the new DPVS-Prednisone is as seamless as possible, we will shortly be taking receipt of our first shipment of the new tablet standard. Once we receive this, we will be performing engineer familiarisation and in-house testing using the standard on our demonstration equipment. We will shortly be contacting certain customers to ask them to be part of our site testing program, which will run alongside our in-house training. The aim of this program is to generate additional data in the field, across a range of sites and instrumentation to provide reassurance to both Omicron and our customers that the new standard can be adopted without issue when it becomes official. The site testing will take place in February, March and April.
Assuming the new standard delivers on the claims made of it by the USP, we anticipate a negligible impact as we migrate across to the new DPVS-Prednisone standard. From the information that the USP has released to date, this should also have no impact on your internal processes or documentation as on paper the changes are akin to a change in batch number. However, it might be pertinent to perform your own internal audit to assess any possible impact.
We hope the above provides you with clarification of the upcoming change, but should you have further questions please do not hesitate to contact us using the following:
Tel: +44 1488 682 700