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News|Articles|March 30, 2015
FDA Issues Guidance on NIR Analytical Procedures
Author(s)Pharmaceutical Technology Editors
The agency outlines recommendations for the development and submission of near infrared analytical procedures.
FDA has issued
According to FDA, the recommendations in the guidance can be applied to other process analytical technologies including Raman, focused beam reflection measurement, particle imaging, and X-ray. The guidance, however, states that it only “pertains to the development and validation of NIR analytical procedures” and does not address set up, qualification, maintenance, or calibration of NIR instruments.
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