<1055> Peptide Mapping

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 23-Feb-2024
Official Date: 1-Dec-2024
Expert Committee: Biologics Monographs 2–Proteins
Coordinating Pharmacopoeia: United States Pharmacopeia

A revision to the harmonized standard for <1055> Biotechnology-Derived Articles-Peptide Mapping has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 1 sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the general chapter of <1055> Biotechnology-Derived Articles-Peptide Mapping has been formally approved by the USP Biologics 2–Proteins Expert Committee in accordance with the Rules and Procedures of the 2020-2025 Council of Experts.

Major changes from the existing USP–NF General Chapter include:

  • The Introduction was revised to define peptide mapping as a chemical identification test.
  • The scope of the chapter was limited to the use of peptide mapping for confirmation of identity.
  • The section heading, “General Considerations for the Development of a Peptide Mapping Procedure was changed to “Development of Peptide Mapping Identity Test Procedure- Points to Consider.”
  • The Development of Peptide Mapping Identity Test Procedure- Points to Consider section was revised including adding a figure that identifies the peptide mapping method and Target Performance Parameters.
  • Edits were made to the Pretreatment, Digestion, Separation and Specificity sections. The heading of “Establishment of Optimal Digestion Conditions” was deleted.
  • The sections, “Experimental Aspects of Peptide Mapping”, “Data Comparison” and “Analysis and Detective of Peptides” were deleted.
  • A section, “Points to Consider Prior to Validation” was added to the chapter.
  • Additionally, minor editorial changes have been made to update the chapter to current USP style.

General Chapter <1055> Biotechnology-Derived Articles-Peptide Mapping will become official on December 1, 2024.

Should you have any questions, please contact Dr. Rebecca Potts (301-816-8567 or rcp@usp.org). For any questions about the PDG and its processes, please see Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).