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Quick Development of a NIRS Method for the Analysis of Moisture, Protein, and Fat in Nutritional Clinical Products

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Abstract

This work describes the approaches used for the quick development and validation of a near-infrared spectroscopy (NIRS) method for the quantitation of major constituents—fat, proteins, and moisture—in finished and intermediate nutritional clinical products. The document also describes the development of identification and qualification methods for the finished products. The approaches included the acquisition of spectra from previously manufactured batches in addition to production samples. This approach allows the construction of the calibration equations for the quantitation of the three components, the development of identification and qualification methods, and their validation for four kinds of products in less than 3 months. This procedure may need several months, or even years. Calibration equations for intermediate products were also constructed and validated allowing the quantification of the three constituents in any kind of intermediate product, regardless of the source of fat or protein used in the product. The grouping of all kind of products in the same equation in intermediate product leads to a reduction of the time required for the development of the equations. The method was validated according to FDA requirements; the validation procedure is also described. ISO Official Methods of Analysis were used as reference for the construction of the models. The method has been successfully implemented for in-process control and finished product quality control.

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Authors state that they have written an entirely original work, and if the authors have used the work and/or words of others, they have been appropriately cited or quoted. Authorship has been limited to those who have made a significant contribution to the conception, design, execution, or interpretation of the reported study. There is not any conflict of interest that might be construed to influence the results or interpretation of their manuscript. This article does not contain any studies with human or animal subjects

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Authors and Affiliations

  1. Quality Assurance Department, Abbott Nutrition Supply Chain, Abbott Laboratories S. L., Camino de Purchil 68, 18004, Granada, Spain

    F. J. Camino-Sánchez, B. Delgado-Moreno & P. Navarro-Fuentes

  2. Research Group of Analytical Chemistry and Life Sciences, Department of Analytical Chemistry, University of Granada, Campus of Fuentenueva, 18071, Granada, Spain

    F. J. Camino-Sánchez

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  1. F. J. Camino-Sánchez
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  2. B. Delgado-Moreno
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  3. P. Navarro-Fuentes
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Correspondence to F. J. Camino-Sánchez.

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Camino-Sánchez, F.J., Delgado-Moreno, B. & Navarro-Fuentes, P. Quick Development of a NIRS Method for the Analysis of Moisture, Protein, and Fat in Nutritional Clinical Products. Food Anal. Methods 8, 1758–1770 (2015). https://doi.org/10.1007/s12161-014-0058-6

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  • DOI: https://doi.org/10.1007/s12161-014-0058-6

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