Revision of USP Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice
Recommendation
Tuesday, 14 January 2025 13.00 - 17.30 h
In the Pharmacopeial Forum, PF 49(3), proposals of revised USP General Chapters <782> Vibrational Circular Dichroism Spectroscopy and <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice were published for comments.
In both cases, it is about to replace carbon tetrachloride (CCl4), a highly hazardous reagents, with deuterated chloroform (CDCl3), a less toxic solvent. The briefing notes state that "this revision is aligned with USP policy to contribute to global efforts to minimize negative environmental impact." In addition to that change, minor editorial changes to update the chapters to current USP style have been made.
Concerning Chapter <782> Vibrational Circular Dichroism Spectroscopy, the new proposal is based on the version of the chapter official as of 01 December 2016. The changes are limited to the replacement of carbon tetrachloride by deuterated chloroform in several places in the subchapters 2 and 3.
The draft of the new Chapter <1782> Vibrational Circular Dichroism Spectroscopy - Theory and Practice is based on the version of the chapter official as of 01 May 2020. In addition to the replacement of the solvent in the running text, it also provides new figures of spectra recorded from substances dissolved in deuterated chloroform.
Comments on both revised chapters can be submitted from now on until 31 July 2023.
The drafts are available after registration to the Pharmacopeial Forum.
Related GMP News
11.12.2024Another FDA Warning Letter Based on Review of Records
04.12.2024FDA Warning Letter to South African OTC Drug Manufacturer
02.12.2024How to keep Analytical Systems Current and Compliant
27.11.2024FDA Inspections in the EU: Warning Letter to Italian OTC Drug Manufacturer
21.11.2024New GMP Journal Article on Analytical Instrument Qualification and System Validation
21.11.2024FDA Warns Chinese OTC Drug Manufacturer Following Review of Records