USP Science & Research

Since the first detection of #nitrosamines in anti-hypertensive drugs in 2018, the impurities have been found in other commonly used medicines, prompting recalls and action by regulators around the world. At unsafe levels, nitrosamine impurities pose a potential risk of harm to patients and can undermine trust in medicine quality. Pharmaceutical impurities have the potential to disrupt drug supply chains and even lead to shortages resulting from product recalls and withdrawals. Meet Naiffer Romero, a Principal Scientist at USP. He serves as the community manager for the Nitrosamines Exchange, a knowledge-based online community built by USP where 4,500+ members around the world are dedicating their time and individual expertise to information-sharing that is helping advance the science and understanding of nitrosamines. Membership is free. Join us in the discussion! ➡ https://ow.ly/IAOp50Rgv2t #USPScience

“Volunteering with US Pharmacopeia allows me to address the “why” not just the “what” as a QC Chemist working to promote quality and precision across the pharmaceutical manufacturing lifecycle. It’s an opportunity to use my voice as an independent scientific expert and an individual consumer to advance global public health.” 💬 James Salas, USP Expert Volunteer Why should you consider becoming a #USPExpertVolunteer? Hear more from James about how this experience empowers him to make a real difference, in more ways than one, and get inspired to amplify your impact with USP. Join James and apply to serve in our upcoming 2025-2030 cycle: Bit.ly/USPExpertVolunteer

🎉 Exciting Microneedle News! 🎉 Mark your calendars and plan to attend these 2 FREE webinars discussing various development aspects of drug loaded microneedles. Details below. The first webinar Dr. Caroline Strasinger will discuss regulatory considerations for microneedle products.  📅 Date: July 26, 2024 🕛 Time: 12:00 pm ET 💡 Topic: Piercing a Way through Regulatory Submission? Considerations for Microneedle Development and Application Submission. 🎤 Speaker: Caroline Strasinger, PhD, Master Reviewer, CDER, U.S. Food and Drug Administration 🔗 Join Zoom Meeting: https://lnkd.in/gJeKM7JD The second FREE webinar is co-hosted by the American Association of Pharmaceutical Scientists (AAPS) and the United States Pharmacopeia (USP) discussing the USP Panel Findings on Product Quality and Performance for Drug Loaded Microneedles. 📅 **Date:** September 10, 2024 ⏰ **Time:** 12:00 – 1:30 PM ET 📍 **Location:** Online Webinar Speaker and panelists include renowned scientists and industry leaders who will share their expertise and answer your questions in a live Q&A session. Also, want to hear audience views on input into the potential creation of a USP information chapter for Microneedle Array Patches. 👉 **Register now:** https://lnkd.in/g6isawDi  (Note registration will require those who are not AAPS members to create a free account.) Don't miss these opportunities to enhance your knowledge and network with fellow professionals! #Microneedles #DrugDelivery #AAPS #USP

Do not miss the USP's Free Virtual E&L Open Forum (Webinar) featuring an impressive line up of speakers from industry, gain Industry Insights, supplemented by E&L activities updates from USP. https://lnkd.in/e76HRfCr

Residual host cell proteins (HCPs) are critical quality attributes in biotherapeutics, impacting patient safety and product efficacy. Mass spectrometry (MS) is gaining prominence for its precision in identifying and quantifying individual HCPs, playing a vital role in risk assessment, process optimization, and quality control of biotherapeutic products. This presentation will delve into the USP's initiatives to enhance the quality and consistency of MS-based HCP analysis. Register today! https://ow.ly/zBaA50SIsOy #USPScience

#nitrosamines ... Are you dealing with N-nitroso-Ticagrelor in your product?? 🛑 Not TOO FAST!! 🛑 If you decide to skip risk assessment or your assessment is solely based on the letter/checklist provided by your supplier, or you relied on a Google search to ID your risk. 🌪️ You are about to embark on a wild ride!! This is one of the many nitrosamine examples that highlight why 1️⃣ a comprehensive risk assessment is necessary and 2️⃣ why collecting checklists and letters of 'free of nitrosamines' without the necessary supporting data is simply a waste of time, money, and energy! 🗑 More surprising is that commercial suppliers of reference standards offer this impurity as a product on their catalogs and websites, 'available for shipping'. What are they putting inside those vials if the molecule can NOT be synthesized? 😩 Learn about this case and sharpen your risk assessment skills at US Pharmacopeia Nitrosamines Exchange Community, a knowledge-based community for all things Nitrosamines. #nitrosaminas #nitrosamine #nitrosaminne #nitrosammine

For folks making #Oligonucleotide therapies or #CGT #Cellandgenetherapies / #ATMP (#AdvancedTherapyMedicinalProducts) or #DNA #Vaccines: my US Pharmacopeia teammates Sarita Kattel and Xiaolei Zhuang wrote this very nice Application Note on making sure the raw materials you're using are of good quality before using them in the actual manufacturing process. Download it by visiting: https://lnkd.in/eh7i_fDu.

Reminder that public comment period for Proposed Revisions to USP General Chapter <7> Labeling ends July 31, 2024. Proposed revisions to USP General Chapter <7> Labeling include the removal of ratio expressions of strength in multi-entity drug products, such as Lidocaine and Epinephrine. Learn about this and other proposed revisions here➡️: https://ow.ly/IVTb50SbfqA. Submit your comments by July 31, 2024. #USPScience

Did you know that the inactive ingredients in medicines are important to a drug’s safety and efficacy? Inactive ingredients, also known as excipients, can make up the majority of a medicine’s composition – up to 90 percent of a medicine’s total ingredients. Constituting such a significant portion of a medicine's total ingredients – and such important roles in a drug’s function – it’s no wonder that quality issues or shortages in excipients can lead to supply chain disruptions, drug shortages, and adverse patient outcomes. Read this article to learn more about USP's policy recommendations to help ensure medicine quality and supply chain resilience ⤵

#USPScience: A new app note, now available for free in the Analytical Hub at the Nitrosamines Exchange that helps to tackle nitrites found in commonly used excipients. Read this article to learn more: ⤵ #Nitrosamines