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Submitted URL: https://go.usp.org/e/323321/2024-01-12/92ct22/775550143/h/Z-Z4ZsmHPJJ8cZYrfHGfaBf4ElA1E6Re2tzWfUOUiKk
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Effective URL: https://www.usp.org/
Submission: On January 14 via manual from US — Scanned from DE
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* Get Involved * Partner * Volunteer * Provide Input STANDARDS BUILD Trust in medicines AND A STRONGER SUPPLY CHAIN Read how standards strengthen the supply chain Our portfolio of solutions USP is addressing quality assurance, enhancing regulatory predictability, and helping manufacturers distribute quality medicines, dietary supplements and foods. See our solutions Go to the USP Store USP–NF updates New and Updated Notices New and Updated Revision Bulletins New and Updated Interim Revision Announcements New Pending Notices of Intent to Revise Cumulative List of Revisions > AS NEW TECHNOLOGIES EMERGE, WE ADAPT, GROW AND EVOLVE WITH SCIENCE AND > MEDICINE. Qualify your dissolution apparatus with the new USP DPVS – Prednisone Reference Standard Learn about dissolution testing Quality standards for Biologics Learn about our efforts RECOMBINANT THERAPEUTIC PROTEINS, VACCINES, BLOOD COMPONENTS, TISSUES AND GENE THERAPIES. Browse biologics resources FEATURED SOLUTIONS Learn about USP’s portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. Previous PHARMACEUTICAL ANALYTICAL IMPURITIES To protect patients, the FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers to assess and control the presence of nitrosamine impurities in medicines. Get more information USP OFFICIAL REFERENCE STANDARDS USP offers over 7,000 USP Reference Standards, highly characterized physical specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators. Search and buy MEDICINE SUPPLY MAP USP’s Medicine Supply Map (MSM) is a graph-based predictive data model that generates insights into the upstream medicine supply chain. Using machine learning and advanced analytics, MSM identifies, characterizes, and quantifies factors linked to supply chain disruptions for drug ingredients and finished drug products. Learn more PHARMACEUTICAL ANALYTICAL IMPURITIES To protect patients, the FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers to assess and control the presence of nitrosamine impurities in medicines. Get more information USP OFFICIAL REFERENCE STANDARDS USP offers over 7,000 USP Reference Standards, highly characterized physical specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators. Search and buy MEDICINE SUPPLY MAP USP’s Medicine Supply Map (MSM) is a graph-based predictive data model that generates insights into the upstream medicine supply chain. Using machine learning and advanced analytics, MSM identifies, characterizes, and quantifies factors linked to supply chain disruptions for drug ingredients and finished drug products. Learn more PHARMACEUTICAL ANALYTICAL IMPURITIES To protect patients, the FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers to assess and control the presence of nitrosamine impurities in medicines. Get more information Next build trust in medicines IMPORTANT MESSAGE × I agree False SOCIAL MEDIA * Linked In * Twitter * Facebook * You Tube * QualityMatters Blog SOCIAL MEDIA 3 * Linked In * Twitter * Facebook * You Tube * QualityMatters Blog * About ABOUT USP * About USP * Leadership * USP Convention * USP Volunteers * Careers * Legal Recognition * Newsroom * Two Hundred Years of Building Trust * Annual Report * Our Impact OUR IMPACT * Complex Generics * Medicines Supply Chain * Impurities * Healthcare Quality & Safety Standards * Global Public Health * Public Policy * Harmonized Standards * Our Work OUR WORK OVERVIEW * Biologics * Compounding Standards * Dietary Supplements & Herbal Medicines * Excipients * Federal Government Practice * Food Safety & Integrity * Reference Standards * Small Molecules * Products & Solutions PRODUCTS & SOLUTIONS OVERVIEW * All Products * New Products * New Lots * Coming Soon * Biologics * Antibiotics * Carbohydrates * Cell, Gene & Tissues * Critical Reagents * Heparins * Microbiology * Monoclonal Antibodies * Oligonucleotides * Peptides * Proteins * Raw Materials * Vaccines * Training Courses * Coming Soon * Dietary Supplements & Herbal Medicines * Amino Acids * Botanicals-Herbal Medicines * Cannabis * Minerals * Others-Dietary Supplements * Vitamins * Training Courses * Coming Soon * Dietary Supplements Compendia (DSC) * Herbal Medicines Compendia (HMC) * Dissolution * Excipients * Binders & Fillers * Buffers & pH Modifiers * Chelating Agents * Coatings * Diluents * Disintegrants * Dual Active * Emollients & Ointments * Flavor & Coloring Agents * Glidants & Lubricants * Impurity * Preservatives * Solvents * Surfactants * Training Courses * Foods * Adulterants * Amino Acids * Carbohydrates * Colors * Fats & Oils * Flavors & Fragrances * Functional Ingredients * Infant Formula Ingredients * Matrix Based Materials * Preservatives * Proteins & Amino Acids * Proteins & Amino Acids * Sweeteners * Training Courses * FCC Analytical Materials * Food Chemical Codex (FCC) * Impurities * Reference Standards * Pharmaceutical Analytical Impurities (PAIs) * Nitrosamines * Small Molecules * Associated Drug Substances * Impurities * System Suitability * Training Courses * Coming Soon * Authorized Distributors * Advanced Manufacturing * Continuous Manufacturing Knowledge Center * R&D Analytical Solutions * Pharmaceutical Continuous Manufacturing: USP Technical Guide * Verification Services * Quality Solutions Sheets * Pharmatech Associates * USP-NF * Compendial Tools * USP-ID, Delivered by Mestrelab Research * Newsletters & Updates * Events & Training EVENTS & TRAINING * Search Events and Training * USP Education, Courses & Webinars * Workshops * Expert Body Meetings * Open/Stakeholder Forums * User Forums * Get Involved GET INVOLVED OVERVIEW * Partner * New or Revised Standards * Reference Standards * Compounding Monographs * Submission Guidelines * Donor Recognition * Volunteer * How to Become a Volunteer * View Volunteer Opportunities * Provide Input * Comment on Proposed Standards * Review Work Plans * Observe a Committee Meeting * Open/Stakeholder Forums Menu BOTTOM MENU * Legal Notices * Privacy Policy * Terms of Use * Quality Policy & ISO Accreditation * Sitemap * © The United States Pharmacopeial Convention × × Menu WE USE COOKIES ON THIS SITE TO ENHANCE YOUR USER EXPERIENCE By clicking the Accept button, you agree to us doing so. 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