2015–2020 General Chapters - Chemical Analysis Expert Committee Work Plan

Contact

Kahkashan Zaidi, Ph.D. Principal Scientific Liaison - General Chapters, kxz@usp.org

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

Download Roster Observe a Meeting

Upcoming Official Meetings

  • October 3–4, 2017 face-to-face meeting at USP–U.S., Rockville

Past Meetings – Executive Summaries

Latest Updates

  • October 3–4, 2017 face-to-face meeting at USP–U.S., Rockville

Focus Areas

  • Standards and guidance of methods for chemical analysis, including but not limited to chromatography, spectroscopy, wet chemistry, and regulatory sciences.

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, metal or water analysis).

Key Issues

  • Bring to official the new USP Elemental Impurities general chapters
  • Update 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
  • Modernization of General Chapter <191> Identification Tests – General to supersede chemical tests with instrumental procedures

Subgroups and Expert Panels

  • Spectroscopy
  • Chromatography
  • Wet chemistry
  • Regulatory compliance
  • Reference standards
  • Specific elements
  • Elemental Impurities
  • Impurities in Drug Products
  • Identification Tests
  • Chemometrics
  • Residual Solvents
  • Validation and Verification
  • Analytical Instrument Qualification
  • Titrimetry
  • Water
  • Nitrogen Determination
  • Nanotechnology
  • Elemental Impurities and Plastic Materials of Construction (joint with Packaging & Distribution Expert Committee)
  • Water and Plastic Packaging Systems for Pharmaceutical Use (joint with Packaging & Distribution Expert Committee)

Ballot Results and Standards Development