Abstract

Introduction In recent years, the simplicity and expeditiousness of near infrared spectroscopy (NIRS) have substantially fostered its use for the pharmaceutical analysis. Developing appropriate NIRS calibration models requires careful selection of calibration sets containing all potential sources of variability in the production samples to be analysed. Once the whole variability is included, the predictive capacity of the calculated models is enhanced and those can be considered useful in the quality control. In this work, we assessed three different calibration strategies for the quantification of the active pharmaceutical ingredient (API) in a pharmaceutical granulate in low concentration (10 mg g−1). Such strategies were used to construct calibration models, allowing all potential variability in new, unknown samples to be considered.

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