U.S. Pharmacopeia News
USP Bundle Discount Program
2 April 2025
Until August 31st, 2025 we’re offering 6 customizable bundles of selected @US-Pharmacopeia products so you can get what you need for your quality control—at a better price. Just order at least one of each product in the bundle, choose your quantities, and enjoy a 15% discount.
Each bundle is a mix of API and/or IMP and/or PAI. Check out the bundles available in the Quality Solution Sheets. The product codes are clickable and take you directly to each product in our shop.
Labmix24 Webshop search: For your convenience, whenever you search for a bundled product, we’ve temporarily modified our search so that all products in the bundle appear.
Discount applies only to USP products in the bundle and cannot be combined with other discounts.
First releases of USP reference standards
Updated 28 February 2025
View the latest releases of new USP Reference Standards in the downloadable, interactive document below.
Concerned about nitrosamine recalls?
Identify, detect, and quantify nitrosamines with confidence
To confirm the presence and formation of NDSRIs in your drug product, it’s essential to develop suitable analytical methods using authentic, well-characterized NDSRI reference materials. Reference material quality and reliability are crucial for confidently identifying, detecting and quantifying nitrosamines at trace levels (ppb) across various formulations. For a dependable source of NDSRI and small-molecule nitrosamine reference materials, turn to USP.
To learn more, download our flyer about USP's solutions for nitrosamine impurities.
First releases of USP reference standards
Updated 29 January 2025
View the latest releases of new USP Reference Standards in the downloadable, interactive document below.
New QSS available
Updated 17 January 2025
This month, new QSS have been uploaded for:
Acetyltributyl Citrate, Albendazole, Bexarotene, Caffeine, Carglumic Acid, Carvedilol, Cefdinir, Cetostearyl Alcohol, Desvenlafaxine, Erlotinib, Flurbiprofen, Glucagon, Gramicidin, Insulin, Leuprolide, Levetiracetam, Lurasidone, Meperidine, Nadolol, Oxycodone, Oxytocin, Paliperidone, Pantoprazole Sodium, Permetrexed, Permethrin, Pentazocine, Pimecrolimus, Piperacillin, Propranolol Hydrochloride, Regorafenib, Rotigotine, Sirolimus, Sodium Alginate, Sorafenib, Sucralose, Sunitinib, Tenofovir Disoproxil Fumarate, Terbutaline, Teriflunomide, and Tobramycin.
The QSS can be found on the product details page for all associated products.
First releases of USP reference standards
Updated 19 September 2024
View the latest releases of new USP Reference Standards in the downloadable, interactive documents below.
New QSS available
Updated 10 June 2024
This month, new QSS have been uploaded for:
Acetyltributyl Citrate, Albendazole, Bexarotene, Caffeine, Carglumic Acid, Carvedilol, Cefdinir, Cetostearyl Alcohol, Desvenlafaxine, Erlotinib, Flurbiprofen, Glucagon, Gramicidin, Insulin, Leuprolide, Levetiracetam, Lurasidone, Meperidine, Nadolol, Oxycodone, Oxytocin, Paliperidone, Pantoprazole Sodium, Permetrexed, Permethrin, Pentazocine, Pimecrolimus, Piperacillin, Propranolol Hydrochloride, Regorafenib, Rotigotine, Sirolimus, Sodium Alginate, Sorafenib, Sucralose, Sunitinib, Tenofovir Disoproxil Fumarate, Terbutaline, Teriflunomide, and Tobramycin.
The QSS can be found on the product details page for all associated products.
Reduced pricing on select USP PAIs
June 6th, 2024
Since its launch in 2021, the US Pharmacopeia Pharmaceutical Analytical Impurities (PAIs) range, used together with USP Reference Standards (USP RS), has provided pharmaceutical manufacturers with a comprehensive solution for analytical testing and research.
The PAI product line has now grown to over 550 impurities covering over 130 active pharmaceutical ingredients across over 20 therapeutic areas. The PAI portfolio, like USP RS, can help you save time and resources, and reduce risks associated with quality and consistency.
To support your work on impurity testing and profiling of drugs, we have reduced the prices (up to 50% in some cases) of select Pharmaceutical Analytical Impurities.
Download the list of Pharmaceutical Analytical Impurities with reduced prices. Clickable links take you directly to each product in our web shop.
The sale ends July 31st! Contact us for more information at info@labmix24.com or +49 2852 96064 00.
First releases of USP reference standards
Updated 24 May 2024
View the latest releases of new USP Reference Standards in the downloadable, interactive documents below.
New USP reference standards available
Updated 3 January 2024
View the latest releases of new USP Reference Standards in the downloadable, interactive document below.
New QSS available
Updated 13 December 2023
This month, new QSS have been uploaded for Asparagine, Cefoxitin, Clioquinol, Eptifibatide, Etodolac, Isoproterenol Hydrochloride, Mometasone Furoate, Rivaroxaban, Sildenafil, and Tetracycline Hydrochloride. These can be found on the product details page for all associated products.
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.