ABSTRACT

Near-infrared spectroscopy (NIRS) continues to grow in importance as a useful analytical technique. The pharmaceutical industry has been cautiously slow to accept NIRS as a commonly used technique, probably because of the absence of primary absorption bands. In pharmaceutical applications, NIRS is more often used as a secondary analytical technique than as a primary tool. NIRS instruments are typically designed as either transmittance or reflectance, with some allowing the user to switch from one to the other. Manufacturers of NIRS instrumentation include software packages that allow the operator to predict analytical results on data files that have been stored, thus allowing for validation of the calibration equation and testing for errors in the developed calibration. NIRS is a non-destructive method, thus, 100% inspection of batches is theoretically possible, allowing better control of product uniformity. NIRS is useful for the analysis of both raw materials and finished dosage forms.