Revision of USP chapter on NIR

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Recommendation

7/8 October 2025

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Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes

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