Revision of the USP Chapter on Spectroscopic Methods

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Revision of the USP Chapter on Spectroscopic Methods
A new concept for the representation of different analytical and spectroscopic methods (AAS, IR, UV, etc.) has been presented as general chapter in the USP. In the future, there should be two general chapters for each method. The concrete implementation is planned in the USP38/NF33. Read more here in the News.

GMP News: Revision of the USP Chapter on Spectroscopic Methods

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.

 

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One thought on “Revision of the USP Chapter on Spectroscopic Methods

    DR ANTHONY MELVIN CRASTO Ph.D responded:
    May 2, 2014 at 3:38 am

    Reblogged this on New Drug Approvals.

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