Revision of USP chapter on NIR
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
NIR is a vibrational spectroscopic technique which, like IR or Raman, is frequently used in the inspection of incoming active ingredients and excipients.
The USP's new proposals for the chapters <856> and <1119> on near-infrared spectroscopy were now published in Pharmacopeial Forum (PF) 43 (4). Former proposals have been revised due to the comments received.
The USP received a number of comments asking for precise specifications for multivariate calibrations since the former version of the chapter only focussed on univaritate approaches.
Furthermore, reference to the new USP chapter <1039> Chemometrics has been established. This chapter is now official and includes multivariate calibrations.
The main focus of chapter <856> lies on the qualification, validation and verification of NIR systems.
Opposite that, chapter <1119> focusses on sample preparation, instruments, methods as well as the qualitative and quantitative NIR analysis.
Further information about the revision of General Chapters <856> and <1119> on near-infrared spectroscopy can be found in Pharmacopeial Forum PF, 43(4) on the USP website.
Source: USP
Related GMP News
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts
21.10.2026FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus
07.10.2026Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination