Development and validation of HPLC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products

Xiao, Baiming; Gozo, Stephen K.; Herz, Lori

doi:10.1016/j.jpba.2006.08.020

Cited by 14 publications

(2 citation statements)

References 9 publications

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“…Drug manufacturers use antioxidants, plasticizers, accelerators, and activators in order to achieve the required performance of their products. Consequently, the quality of the packaging material might have various negative effects on the pharmaceutical products and also be harmful to the human body [ 3 , 4 ]. The package of pharmaceutical products should be suitable for the standard of clinic and should have the following characteristics: protection, compatibility, safety, and functionality.…”

Section: Introductionmentioning

confidence: 99%

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

Zhao

Zhang³

et al. 2020

Journal of Analytical Methods in Chemistry

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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.

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Section: Introductionmentioning

confidence: 99%

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

Zhao

Zhang³

et al. 2020

Journal of Analytical Methods in Chemistry

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“…Pharmaceutical packaging, including glass, rubber, plastics, ceramics and metal, is an inescapable component of any drug [1]. It has been established that pharmaceutical packaging material is critical to the stability of a drug, because the packaging materials [2], [3], [4] can directly influence the clinical curative effect of the pharmaceuticals [5], [6]. Furthermore, the more complex the packaging materials, the greater the risk to the patients, as there are more migrant compounds that may leach out of the packaging materials and into the drug during production and storage [7], [8].…”

Section: Introductionmentioning

confidence: 99%

Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry

Meng

Gao

et al. 2019

Journal of Pharmaceutical Analysis

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A simple, rapid, and sensitive gas chromatography-mass spectrometry (GC-MS) method was developed and validated for the simultaneous determination of two fatty acids, methyl hexadecanoate (MH) and methyl stearate (MS), to allow the evaluation of packaging-drug compatibility. The two migrants were quantified in selective ion-monitoring (SIM) mode, with limits of detection (LOD) of 0.0030 μg/mL and 0.0121 μg/mL. Linear calibration curves for MH and MS were obtained in the concentration ranges of 0.1011–5.0570 μg/mL and 0.2015–10.0740 μg/mL, respectively. The developed method was successfully applied to estimate the safety of the injection of recombinant antitumor-antivirus protein (RAAP). The results showed that the possible maximum daily intake was 3.0 ng and 12.1 ng for MH and MS, respectively. As these values were both below the permitted daily exposure, the migrants can be considered as having low safety risk and do not affect the quality of the injection.

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Material Screening and Characterization

Jenke¹

2008

Compatibility of Pharmaceutical Products and Contact Materials

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Development and validation of HPLC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products

Cited by 14 publications

References 9 publications

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

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

Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry

Material Screening and Characterization

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