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

Contact

Antonio Hernández-Cardoso, M.Sc., Senior Scientific Liaison - General Chapters, ahc@usp.org

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

Download Roster Observe a Meeting

Upcoming Official Meetings

  • September 14, 2017 face-to-face meeting at USP–U.S., Rockville

Past Meetings – Executive Summaries

Latest Updates

  • September 14, 2017 face-to-face meeting at USP–U.S., Rockville
    Download Agenda

Focus Areas

  • Standards and guidance of methods for physical analysis of powders, liquids, excipients, drug substances, and compounded or formulated drugs products

Expert Committee Charge

  • General Chapters – Physical Analysis Expert Committee is responsible for developing new and revising existing general chapters related to physical analysis (e.g., particles, powders, rheology).

Key Issues

  • Initiating and developing general chapters designed to help users of the USP–NF in the application of analytical methods for physical analysis of powders, liquids, and compounded or formulated drugs products
  • Supporting and evolving existing general chapters concerned with physical characterization of excipients and drug substances

Subgroups and Expert Panels

  • Powders
  • Rheology
  • Crystals
  • Microscopy
  • Solutions
  • Particles
  • Color
  • Melting Range and Thermal Analysis
  • Physical Stability
  • Nanotechnology (in conjunction with the General Chapters–Chemical Analysis and General Chapters–Dosage Forms ECs)
  • Osmolality and Osmolarity
  • Excipients Performance
  • Physical Stability (in conjunction with the General Chapters–Dosage Forms EC)
  • Viscosity and Rheology for Pharmaceutical Dosage Forms (in conjunction with the General Chapters–Dosage Forms EC)
  • Collaborative Group with the Excipient Monographs 1 and 2 ECs

Ballot Results and Standards-Development

Historic Prospectus