Nitrogen dioxide sterilization of a set of five ophthalmic active pharmaceutical ingredients: Impact on impurity profile and content.

Autor: Vanneste E; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium., Speleers Q; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium., Meyers A; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium., Krupianskaya K; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium., Gillet A; Sterigenics NV, A Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Croonenborghs B; Sterigenics NV, A Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., DeMent A; Sterigenics NV, A Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Haghedooren E; Sterigenics NV, A Sotera Health Division, 2015 Spring Road 650, Oak Brook, IL 60523, United States., Van Schepdael A; KU Leuven - University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, Leuven 3000, Belgium. Electronic address: ann.vanschepdael@kuleuven.be.

Publikováno v: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Nov 22; Vol. 254, pp. 116578. Date of Electronic Publication: 2024 Nov 22.