Interested in learning more about the work of this Expert Committee?
September 29, 2020; October 27, 2020; January 5, 2021; February 23, 2021; May 6, 2021
- 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).
- 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
- 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
- Reference Standards
- Specific Elements
- Water Determination
- Wet Chemistry
- Chemometrics and Multivariate Analysis
- Process Analytical Technology
- Water Activity
- 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.