Revision of USP chapter on NIR
Recommendation

5-7 May 2026
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
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
23.04.2026Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1
22.04.2026USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)
08.04.2026FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence
01.04.2026FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
31.03.2026Questions and Answers on System Suitability Tests (SST) - Part 3
31.03.2026Statistical Process Control (SPC) - Survey Result Report now Available


