AI Article Synopsis
- The accuracy of reference values is crucial for the quality of near-infrared (NIR) models used in determining water content in freeze-dried meningococcal vaccines.
- A new analytical method was developed, and an experimental design called the standard addition method (SAM) was employed to assess both calibration uncertainties and systematic errors from the reference Karl-Fischer method.
- The NIR model effectively measured water content within a range of 1.0-6.7% and demonstrated a slope of 1.01 in proportional error assessment, confirming its superiority over the reference method for evaluating water content variability and stability.
Article Abstract
Accuracy of reference values obtained by the reference method is essential to ensure the quality of a near-infrared (NIR) model. The purpose of this study was to assess the accuracy of a newly developed NIR analytical method for the determination of water content in a freeze-dried meningococcal vaccine by evaluating not only uncertainties associated with the calibration model and NIR measurement procedures but also systematic error arising from the reference Karl-Fischer method. An experimental design based on the standard addition method (SAM) in freeze-dried vaccines is proposed for total error assessment of the NIR analytical system. The accuracy profile showed that the NIR model successfully determined water content over the 1.0-6.7% range. The SAM enabled overall proportional error assessment, which yielded a slope of 1.01. The present study confirmed the suitability of the proposed NIR analytical method for the determination of water content in the freeze-dried meningococcal vaccine. Furthermore, assessment of the overall proportional error proved that the NIR analytical method could be used to accurately estimate differences in water content, therein surpassing the reference method as the method of choice for determining intra- or interbatch variability as well as stability.
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| http://dx.doi.org/10.1016/j.talanta.2019.120659 | DOI Listing |
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