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# Guide on Near Infrared Analytical Procedures
- URL: https://www.fdaweb.com/guide-on-near-infrared-analytical-procedures/
- Published: 2021-08-06T12:00:00.000Z
- Updated: 2026-09-14T17:09:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149880

FDA has issued a [final guidance](https://www.fda.gov/media/91343/download?ref=fdaweb.com) entitled *Development and Submission of Near Infrared Analytical Procedures*. The document provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. FDA intends to issue recommendations specific to NIR methods used for biological products under biologics license applications in a future revision to the guidance. Additionally, the guidance provides recommendations for submitting NIR documentation in applications