2020–2025 General Chapters - Chemical Analysis Expert Committee Work Plan

Interested in learning more about the work of this Expert Committee?

Download Roster Observe a Meeting Upcoming Meetings

September 29, 2020; October 27, 2020; January 5, 2021; February 23, 2021; May 6, 2021

Focus Areas

  • Chromatography
  • Spectroscopy
  • Wet chemistry
  • Impurities (organic, inorganic, genotoxic, and residual solvents)
  • Water for pharmaceutical uses
  • Continuous manufacturing
  • Light scattering techniques 

Expert Committee Charge

The General Chapters – Chemical Analysis Expert Committee is responsible for developing new and revising existing general chapters related to chemical analysis (e.g. chromatography, spectroscopy, wet chemistry).

Key Issues

  • Develop general chapter(s) on genotoxic impurities, such as nitrosamines, in pharmaceuticals.
  • Update new USP Elemental Impurities general chapters
  • Modernize existing element specific chapters by including instrumental techniques.
  • Update existing and develop new spectroscopy general chapters with consistent content and format
  • Continue efforts to update and harmonize chromatography general chapters
  • Continue efforts to update, develop, or harmonize pharmaceutical water general chapters and monographs
  • Update General Chapter <467> Residual Solvents to simplify and improve readability
  • Implementation of new chapter <476> and the revised chapter <1086> for organic impurities in drug substances and drug products
  • Modernization of General Chapter <191> Identification Tests – General to supersede chemical tests with instrumental procedures
  • Develop new and update existing general chapters for techniques that support process analytical technology for on-line and in-line measurements
  • Develop new chapters for analytical techniques based on scattering phenomena.

Associated Expert Bodies

Expert Panels

  • Analytical Methodologies Based on Scattering Phenomena
  • Continuous Manufacturing
  • Identification Tests
  • Organic Impurities in Drug Substances and Drug Products
  • Quantitative Nuclear Magnetic Resonance
  • Water for Analytical and Pharmaceutical Purposes

Subcommittees

  • Chromatography
  • Reference Standards
  • Specific Elements
  • Spectroscopy
  • Titrimetry
  • Water Determination
  • Wet Chemistry

Joint Subcommittees

  • Chemometrics and Multivariate Analysis
  • Nanotechnology
  • Nitrosamines
  • Process Analytical Technology
  • Water Activity

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).  
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here. 

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