Inhibition of water adsorption into polar solid-phase microextraction materials with ultrathin polydimethylsiloxane coating for thermal desorption-gas chromatography analysis

Yan, Xinyu; Zhan, Yingying; Zhong, Dongdong; Li, Yanshuo; Wu, Dapeng

doi:10.1016/j.chroma.2018.10.013

Cited by 6 publications

(2 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In addition, polymers may selectively absorb one component of the mixture, resulting in a change in the composition of the extraction solvent mixture and altered polarity. Additionally, the presence of water in alcohol–water mixtures can create challenges for gas chromatography/mass spectrometry (GC/MS) instruments, potentially causing pressure/flow problems in the fluidics components or damaging the columns or detector. , …”

Section: Extractionmentioning

confidence: 99%

“…Additionally, the presence of water in alcohol− water mixtures can create challenges for gas chromatography/ mass spectrometry (GC/MS) instruments, potentially causing pressure/flow problems in the fluidics components or damaging the columns or detector. 40,41 Finally, another important parameter in extraction study design is the solvent volume to sample ratio. In general, the higher the solvent volume to sample ratio, the greater the extraction yield since the concentration gradient is the driving force for mass transfer of extractables into the solvent.…”

Section: ■ Extractionmentioning

confidence: 99%

See 1 more Smart Citation

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.

View full text Add to dashboard Cite

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.

show abstract

Section: Extractionmentioning

confidence: 99%

Section: ■ Extractionmentioning

confidence: 99%