Silicone-based impurities determination in biopharmaceuticals
Organosilicon-based compounds such as PDMS (low-molecular weight polydimethylsiloxane, i.e., Dimeticone, Simeticone, Antifoam A®) or SAG 471® (modified PDMS) are widely used as antifoam agents or as lubricants in biopharmaceuticals manufacturing. As per ICH Q6B guideline, these are considered as impurities in the final product and residual traces have to be tested to assess product quality.
While FTIR, GPC, (U)HPLC/UV or (U)HPLC/ ELSD are commonly used to characterise and quantify low-molecular weight polymers, these technologies are not sensitive enough for trace analysis. Quality Assistance answered this regulatory need by developing a generic ICP/MS method for residual PDMS determination in biopharmaceuticals.