Migration study of 1,3-butadiene in eye-drop solutions

Pistos, Constantinos; Karampela, Sevasti; Vardakou, Ioanna; Papoutsis, Ioannis; Spiliopoulou, Chara; Athanaselis, Sotiris

doi:10.3109/01480545.2011.607826

Cited by 5 publications

(2 citation statements)

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“…Flame ionization detectors (FIDs) are used as supplemental detectors to MS in GC analysis due to their orthogonal detection mechanism. For example, GC coupled with FID has been used for the analysis of residual solvents and as a supplementary/complementary analytical approach to GC/MS for quantifying analytes. ,, …”

Section: Chemical Analysismentioning

confidence: 99%

“…For example, GC coupled with FID has been used for the analysis of residual solvents 64 and as a supplementary/complementary analytical approach to GC/MS for quantifying analytes. 43,112,113 Semivolatile and Nonvolatile Extractables. LC/MS is a technique used for separation, detection, and quantification of semi-and nonvolatile extractables.…”

Section: ■ Extractionmentioning

confidence: 99%

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Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices

Sussman

Öktem

Isayeva

et al. 2022

ACS Biomater. Sci. Eng.

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The developers of medical devices evaluate the biocompatibility of their device prior to FDA’s review and subsequent introduction to the market. Chemical characterization, described in ISO 10993-18:2020, can generate information for toxicological risk assessment and is an alternative approach for addressing some biocompatibility end points (e.g., systemic toxicity, genotoxicity, carcinogenicity, reproductive/developmental toxicity) that can reduce the time and cost of testing and the need for animal testing. Additionally, chemical characterization can be used to determine whether modifications to the materials and manufacturing processes alter the chemistry of a patient-contacting device to an extent that could impact device safety. Extractables testing is one approach to chemical characterization that employs combinations of non-targeted analysis, non-targeted screening, and/or targeted analysis to establish the identities and quantities of the various chemical constituents that can be released from a device. Due to the difficulty in obtaining a priori information on all the constituents in finished devices, information generation strategies in the form of analytical chemistry testing are often used. Identified and quantified extractables are then assessed using toxicological risk assessment approaches to determine if reported quantities are sufficiently low to overcome the need for further chemical analysis, biological evaluation of select end points, or risk control. For extractables studies to be useful as a screening tool, comprehensive and reliable non-targeted methods are needed. Although non-targeted methods have been adopted by many laboratories, they are laboratory-specific and require expensive analytical instruments and advanced technical expertise to perform. In this Perspective, we describe the elements of extractables studies and provide an overview of the current practices, identified gaps, and emerging practices that may be adopted on a wider scale in the future. This Perspective is outlined according to the steps of an extractables study: information gathering, extraction, extract sample processing, system selection, qualification, quantification, and identification.

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Section: Chemical Analysismentioning

confidence: 99%

Section: ■ Extractionmentioning

confidence: 99%