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Usp catalogue 2023 FAQ
USP Reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators. They are explicitly required in many Pharmacopeial assays and tests and are provided solely for such use.
SDSs are available online for all USP Reference Standards at .usp.org/sds.
The USP 43–NF 38 is the last edition that will be available in print or on a USB flash drive. Future supplements and editions – including the First and Second Supplements to USP 43–NF 38 – will not be printed or on flash drives.
Every five years, USP publishes revised standards for drugs in The United States Pharmacopeia and The National Formulary. These standards are recognized as official by the federal government and are enforceable by the FDA.
A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.
Now in its 43rd edition (from May 2021), the current USP-NF remains true to its original mandate: to be an accessible source of information for quality of prescription, nonprescription, and compounded medicines; excipients; biologics; medical devices; and dietary supplements.
Description : The USPNF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. The current version, USP–NF 2023, Issue 1, will become official on May 1, 2023.
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