Determination of silicone-based impurities in biopharmaceuticals

Organosilicon-based compounds such as PDMS are widely used as antifoam agents or lubricants in biopharmaceutical manufacturing. According to ICH Q6B, these compounds are considered impurities and must be tested to assess product quality. Traditional analytical techniques do not provide sufficient sensitivity for trace-level detection, making a more specific and sensitive approach necessary.

This sheet describes a generic ICP/MS method developed in-house to quantify residual PDMS and related organosilicon compounds in biopharmaceutical matrices. We detail the extraction procedure, calibration strategy and method performance, including sensitivity and accuracy.