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An RPLC Method with CAD for the Quantification of Residual Simethicone in Biologic Products

Ye, Z., Schenk, K., Rauniyar, N., & Han, X. (October 23, 2025). LCGC International.

A reversed-phase liquid chromatography–charged aerosol detector (RPLC–CAD) method was developed and validated per ICH Q2(R1) guidelines for simethicone quantification.

Key Takeaways

  • Simethicone is an effective antifoaming agent but must be removed during downstream purification to meet regulatory standards.
  • The RPLC–CAD method was developed and validated for simethicone quantification, showing high specificity, accuracy, and sensitivity.
  • The method demonstrated a limit of quantitation of 10 ppm and a linear response from 10 to 120 ppm.
  • Simethicone clearance in an IgG1 mAb process showed a >4.0 log₁₀ reduction, confirming effective removal.
  • The study highlights the RPLC–CAD method’s suitability for monitoring residual simethicone and ensuring regulatory compliance.

View on LCGC International

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