<1052> Amino Acid Determination

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 28–Apr–2017
Targeted Official Date: 01–May–2018
Expert Committee: General Chapters—Biological Analysis
Coordinating Pharmacopoeia: USP

A revision to the harmonized standard for General Chapter <1052> Biotechnology-Derived Articles— Amino Acid Analysis has been approved by the Pharmacopeial Discussion Group (PDG) as described in the PDG sign-off cover sheet.  Having reached Stage 6 of the PDG process, General Chapter <1052> Biotechnology-Derived Articles—Amino Acid Analysis has been formally approved by the General Chapters—Biological Analysis Expert Committee in accordance with the Rules and Procedures of the 2015–2020 Council of Experts.

Changes from the existing USP–NF General Chapter include:

  • In the Methods 6 and 7, the text stating that protein standard samples to be used for hydrolysis contain “1 to 8 mol of cysteine” was revised to “1 to 8 mol cysteine per mol protein”.

The <1052> Amino Acid Analysis General Chapter will be incorporated into and become official with the USP 41–NF 36.

Should you have any questions about the <1052> Amino Acid Analysis General Chapter, please contact Elena Curti (301-998-6803 or eac@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Richard Lew (240-221-2060 or rll@usp.org).