U.S. Pharmacopeia News
First releases of USP Reference Standards; new QSS available
Updated 27 November 2023
View the latest releases of new USP Reference Standards in the downloadable, interactive document below.
In addition, new QSS have been uploaded for Amiodarone, Aripiprazole, Atorvastatin Calcium, Celecoxib, Ketoprofen, Leuprolide, Metformin, Octreotide, Oxcarbazepine, Oxytocin, and Teriparatide. These can be found on the product details page for all associated products.
PAI Range expanded to over 400 products
10 November 2023
USP’s Pharmaceutical Analytical Impurities (PAI) product line has hit a major milestone! The PAI portfolio now has over 400 impurity analytical reference materials covering 75 Active Pharmaceutical Ingredients (APIs) across over 15 therapeutic categories. PAI products include impurities listed in USP monographs but not available as USP Reference Standards as well as critical degradants and process impurities.
Finding dependable and trust-worthy suppliers of impurity reference materials can be a major hurdle for any drug developer or manufacturer. The unavailability of quality impurity materials can dramatically hinder your ability to develop robust analytical methods, leading to increased costs and time delays along with increased risk of product release or approval failure.
Drug developers and manufacturers have long relied on USP for pharmacopeial Reference Standards needed to meet regulatory expectations. As a leading provider of official Reference Standards trusted by thousands of manufacturers and regulators around the world, USP offers PAI analytical reference materials to support your impurity-related needs.*
- APIs covered include Duloxetine, Epinephrine, Pregabalin, Amiodarone, Clavulanate Potassium, Azacitidine, Azithromycin, Cobicistat, Ethinyl Estradiol, Rosuvastatin Calcium, Tobramycin, and many more.
- Therapeutic categories covered include cardiovascular, oncology, antibiotics, antivirals, antipsychotics, corticosteroids, and more.
* PAI products are different from official USP Reference Standards. PAI products are not required for compendial compliance.
First releases of USP Reference Standards
Updated 18 September 2023
View the latest releases of new USP Reference Standards in the downloadable, interactive documents below.
Now at Labmix24: USP Quality Solution Sheets
7 September 2023
USP has launched Quality Solution Sheets: an informational resource integrating newly released RS and monographs with all relevant associated physical materials, PAIs, and soon: General Chapters, excipients, education, and other products and services—all in one place.
You’ll now find this resource on our website. If a product is covered by a QSS, you’ll find the QSS under the product's details. Just click on the QSS tile for a convenient, downloadable overview of all related USP products and services—with clickable product codes to take you directly to each product.
The number of USP Quality Solution Sheets is growing. New QSS will be announced here and on our social media, so follow us to stay up to date!
First releases of USP Reference Standards
Updated 1 August 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.