Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection

Abstract

Objective. To establish a method for extraction and determination of antioxidant 264 (2,6-di-tert-butyl-4-methylphenol) in the brominated butyl rubber stopper for injection and migration study in recombinant potent antitumor and antivirus protein injection (Novaferon). Methods. Dichloromethane-ethanol was adopted as the extraction solvent during the process of reflux extraction of antioxidant 264 in the brominated butyl rubber stopper. High-performance liquid chromatography (HPLC) was used for the determination of the migration of antioxidant 264 to Novaferon. The mobile phase consisted of acetonitrile-water (80 : 20, v/v). The flow rate was 1.5 mL/min. The detection wavelength was 280 nm. Results. The linearity range was from 4.003 to 200.150 μg/mL (r2 = 0.99996), and the average recovery of antioxidant 264 was 97.8%. The applicability of the methodology was good, which can be used for the determination of antioxidant 264. The results indicated that antioxidant 264 was not detected in Novaferon after the accelerated test and three months of long-term test. Conclusion. The established validated method in this study can be used for the determination of antioxidant 264 in the rubber stopper, and the brominated butyl rubber stopper has good compatibility with Novaferon.

Overview on Post-Polymerization Functionalization of Butyl Rubber and Properties

“…However, IIR with higher isoprene (greater than 3.0 mol %) content has also been reported for some special applications . IIR is broadly used in adhesive, automotive, pharmaceutical, flexible electronics, and also in various other elastomeric applications. − The exceptional air impermeability property of butyl rubber makes it an efficient candidate for the tire inner liner that holds the air tightly. − Butyl rubber-based microporous materials are also used as a sorbent for the removal of oil spills and aromatic hydrocarbons from seawater. , Due to the very low level of unsaturation, butyl rubber shows superior oxidative and high chemical stability. As compared to other elastomers, IIR shows a relatively better damping property (high damping peak height and broad damping temperature range) which is due to the dense distribution of a large number of methyl side groups. − …”