The United States Pharmacopeia (USP) is hosting a virtual Open Forum on Monday, March 21, 2022, from 7:00-10:00pm EDT to discuss further planned revisions to their amino acid monographs. AHPA joins USP in inviting interested stakeholders to participate in this interactive discussion. Registration is free and required in advance.
Register for this free virtual event on March 21, 2022
Join the discussion!

Amino acids are popular and important ingredients widely used in the dietary supplement, excipient, and pharmaceutical industries. With the global demand for personal well-being and nutritional health supplements at an all-time high, ensuring the quality of amino acid products is more important than ever. The United States Pharmacopeia's (USP) amino acid monographs currently employ titration and thin-layer chromatography (TLC) methods for the assay and impurities procedures, respectively, and are in urgent need of modernizations. Previous efforts to modernize several amino acid monographs with ion-pairing liquid chromatographic methods received significant public comments and did not become official standards.

USP invites interested stakeholders to participate in this Open Forum on Modernization of USP Amino Acid Monographs to discuss further planned revisions to improve these monographs. This interactive Open Forum will be held virtually on Monday, March 21, from 7:00 p.m. – 10:00 p.m. Eastern Daylight Time. Registration is free, and advance registration is required.

The Open Forum is intended for USP to engage stakeholders by discussing USP's modernization plans and obtaining industry feedback on the planned revisions. The objective is to identify any concerns from stakeholders so that, if appropriate, they can be taken into consideration to improve the quality and relevance of the modernized monographs before they are posted in Pharmacopeial Forum for public comments.

Topics to be covered:
  • Background on USP's modernization efforts. Specifically, the efforts to revise the USP Histidine monograph to replace the titration-based Assay and TLC-based Related Compounds procedures.
  • Discussion of known and specified impurities of Histidine.
  • Description of the planned proposal of an NMR method to strengthen the Identification procedure and an LCMS method with single quadrupole mass spectrometer to modernize the Assay and Related Compounds procedures of the USP Histidine monograph.

Who should participate?
  • Amino acid ingredient
  • Dietary supplement manufacturers
  • Suppliers
  • Amino acid testing laboratories
  • Regulators
  • Trade association members

For further information, please get in touch with Jacqueline D. Starkes at jws@usp.org.
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