New: Revised USP Monographs of Spectroscopic Methods
Six updated chapters about Atom Absorption Spectroscopy, Infrared Spectroscopy and UV-Vis Spectroscopy were published in the Pharmacopeial Forum 37 (5) from September 2011. These new chapters should replace the existing General Chapter <851> "Spectrophotometry and Light-Scattering". The General Chapter about Fluorescence Spectroscopy should also be revised in the coming year.
From now on, these topics will always be split into two parts and presented in two different chapters: namely legally binding chapters (<8xy> series) and strong guidance chapters (<18xy> series). Numbers under 1000 are seen as binding whereas numbers over 1000 are rather to be understood as strong guidance.
In concrete terms, following General Chapters are concerned:
- <852> Atomic Absorption Spectroscopy
- <854> Mid-Infrared Spectroscopy
- <857> Ultraviolet-Visible Spectroscopy
- <1852> Atomic Absorption Spectroscopy - Theory and Practice
- <1854> Mid-Infrared Spectroscopy - Theory and Practice
- <1857> Mid-Infrared Spectroscopy - Theory and Practice
Chapters <852>, <854> and <857> all have the same structure, i.e.:
- Introduction
- Qualification
- Procedure
- Validation and verification
For some time now, the access to the Pharmacopoeial Forum has been free. You only need to register. More information can be found here.
These newly proposed USP chapters will also be presented by Dr Chris Burgess during the ECA Education Course "Lab Equipment Qualification" in Amsterdam, Netherlands, from 12-14 October 2011. Dr Burgess is a member of the current "USP Councils of Experts on General Chapters".
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
16.10.2024US FDA Warning Letter: Lab Data Integrity issues
16.10.2024FDA Warning Letter: Component Testing, Validation, and Stability
16.10.2024EDQM publishes New Chapter "Quality of Data" for Comments
16.10.2024USP Chapter <621> Chromatography: Notice of Intent to Revise
15.10.2024Pharmeuropa Text for Comment: HPTLC for Herbal Products
09.10.2024WHO Biowaiver Project Cycle VII (2025) and Results from Cycle VI (2024)