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Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Silicone oil has been widely used to coat the components of container/closure systems for biopharmaceutical products, including syringe barrels and plungers for prefilled syringes and stoppers for glass vials. Drug product formulations are therefore typically in direct contact with the silicone oil coating over long periods of time, causing concern that the silicone oil may leach into the formulations, which may affect the drug product’s purity and efficacy.
eBook: Biologics and Sterile Drug Manufacturing 2019
When referring to this article, please cite it as X. Yu et al., "A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).
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