U.S. Pharmacopeia News
First releases of USP Reference Standards
Updated 22 May 2023
View the latest releases of new USP Reference Standards in the downloadable, interactive documents below.
USP’s new Dissolution Performance Verification Standard – Prednisone (30 tablets) is now available
8 February 2023
Based on stakeholder feedback, USP has developed a new reference standard for Dissolution Performance Verification Testing (PVT). This newly developed reference standard called Dissolution Performance Verification Standard (DPVS) – Prednisone, further enhances the user experience with PVT and demonstrates USP’s continued effort toward providing a comprehensive performance qualification of dissolution apparatus 1 and 2.
The new standard:
- Has increased physical and chemical stability
- Stable throughout its shelf-life, hence lower tablet-to-tablet variability
- Is less sensitive to media degassing and thus more sensitive to critical operational and setup parameters
- Is easy to use
- Ball-shape of the tablet ensures consistent positioning of the tablet in apparatus 1 and 2
- Easy-to-open blister packaging with push-through design
USP Standards protect patients from harmful nitrosamine impurities
Detect and eliminate the presence of nitrosamine contamination in drug manufacturing
Starting in 2018 the presence of nitrosamine impurities was identified in some angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. Subsequently, nitrosamines impurities have been found in additional drug products, leading to a major effort by regulators and industry to reduce or eliminate their presence in the drug supply.
Companies are responsible for understanding their manufacturing processes, which includes identifying and preventing the presence of unacceptable impurities. This involves developing new predictive approaches, along with using suitable methods to detect and control these impurities as well as others that may arise when making changes to manufacturing processes.
USP reference standards support manufacturers and regulators in testing, analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain.