Revision of the USP Chapter on Spectroscopic Methods
Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
In the USP Pharmacopeial Forum 40(1), a "Stimuli to the Revision Process" article states that the responsible working group of the USP has conducted a review of the existing general chapters on spectroscopic methods.
The goal of this review was to establish a uniform concept for all the spectroscopic methods and generate a common format. As a result, consistency in the overall approach and ease of use in the future should also be enabled for the user.
The general chapters smaller than <1.000> show how to correctly use the methods ("suitability for use"), whereas the general chapters greater than <1.000> additionally provide so-called "best practices". Those chapters also include provisions on instrument qualification and on validation of spectroscopic methods.
That's why some of these General USP Chapters have been once again published in this issue of the Pharmacopeial Forum:
<852> Atomic Absorption Spectroscopy
<853> Fluorescence Spectroscopy
<854> Mid-Infrared Spectroscopy
<857> Ultraviolet-Visible Spectroscopy
and as supplement to these chapters:
<1852> Atomic Absorption Spectroscopy - Theory and Practice
<1853> Fluorescence Spectroscopy - Theory and Practice
<1854> Mid-Infrared Spectroscopy - Theory and Practice
All these chapters are planned for the edition USP38/NF33 and will thus become effective in the coming year.
You will find more information on the USP Pharmacopeial Forum website.
PS: Dr Chris Burgess, member of this USP experts group, will present the new USP developments in spectroscopy during the ECA course "Analytical Instrument Qualification" from 19-21 May 2014 in Berlin, Germany.
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