Program

Poster Presentations

Day 1, June 10（Wed.）　　Room P (5F 501+502)

1P-22

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Quantitative Analysis for Poly(dimethylsiloxane) in Water-Soluble Active Pharmaceutical Ingredients Using LC/APCI-MS

(Kirin HD)
^oTakafumi Shanoh, Hiroaki Oi, Mitsuharu Uchino

Polydimethylsiloxane (PDMS), a type of silicone oil, is widely used as a food additive and as oils and greases for manufacturing equipment because of its high chemical stability, posing risks of contamination or residual presence in products. Consequently, quantitative methods using CAD and ¹H NMR have been developed. High-sensitivity approaches such as ICP-MS or EDXRF based on silicon quantification have been considered; however, these techniques cannot distinguish silicon from silicate sources. Previous reports have shown that PDMS in a toluene/methanol mixture produces a characteristic ion at m/z 237 during APCI-MS measurement, suggesting its applicability for quantitative analysis. In this study, we aimed to quantify PDMS in water-soluble active pharmaceutical ingredients. We report the optimization of sample pretreatment and LC conditions, evaluation of manufacturer-dependent differences in PDMS, comparison among MS instruments, and a refined discussion on the formation mechanism of the ion.

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