Elucidating the Variability of Magnesium Stearate and the Correlations With Its Spectroscopic Features.

Abstract The objective of this study is to investigate the variability in physiochemical and spectral properties of commercially available vegetable-grade magnesium stearate (MgSt) samples and to assess the correlation between physiochemical properties and near-infrared and Raman spectroscopic features to determine if fast spectral measurements could be used for physical and chemical evaluation. Thirteen MgSt samples of 9 manufacturer grades were obtained from 3 suppliers. The chemical composition was examined using gas chromatography and loss on drying. The physical characteristics were examined on 3 levels: solid state, particle, and bulk level. Comparing the largest to the smallest test values of 13 samples, the variation of the properties ranged from 7% to 335%, with majority of them varying by more than 100% of the smallest value. The samples could be categorized into 4 groups based on solid state properties (1) monohydrate, (2) dihydrate, (3) mixture of monohydrate and dihydrate, and (4) anhydrous form. Scanning electron microscopy images revealed 2 morphological types: thin, flat, and plate-like crystal habit versus irregular crystal habit. The overall variability was mapped using Principal Component Analysis. The greatest variation was due to different manufacturers and perhaps manufacturing methods and starting materials. Based on correlations to physiochemical properties of MgSt, near-infrared and Raman spectra showed potential as a rapid technique for evaluating the differences in excipient properties. [ABSTRACT FROM AUTHOR]