USP <1119> - Near-Infrared Spectroscopy

What it says

This chapter provides guidance on the use of near-infrared spectroscopy in pharmaceutical analysis. It covers the principles, instrument qualification, and the development and validation of qualitative and quantitative methods, including identification of materials and measurement of attributes such as moisture or content.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It is a fast, non-destructive technique that is often used for raw material identification.
• Methods rely on a reference library or calibration model, which needs to be built from representative samples and maintained.
• Changes in material source or process can affect a model, so performance needs monitoring.

What inspectors look for

• Whether instruments are qualified and performance is checked.
• Whether the calibration model was validated.
• Whether the model is maintained and monitored.

Related regulations