Chromatographic considerations in the standardization of liquid chromatographic methods used for extractables screening

Jenke, Dennis R.; Liu, Norman

doi:10.1080/10826076.2016.1224974

Cited by 16 publications

(8 citation statements)

References 12 publications

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“…For more reliable and reproducible standardizations we used a RRT, which overcomes the uncertainty of the identity of the analyzed substance. 35 Thus, the four isomers of cyclo(Pro–Leu) were injected with a tricosane standard (C 23 H 48 ), and the calculation of RRT was performed, giving rise to the data in Table 2 .…”

Section: Resultsmentioning

confidence: 99%

Diketopiperazines as Cross-Communication Quorum-Sensing Signals between Cronobacter sakazakii and Bacillus cereus

et al. 2017

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Herein, we reveal a second quorum-sensing system produced by Cronobacter sakazakii. A cyclo(l-Pro–l-Leu) diketopiperazine, detected in pure and mixed cultures of C. sakazakii and Bacillus cereus explains the coexistence of both in the same industrial environments. The molecule was identified by gas chromatography–mass spectrometry (GC–MS), 1H, and 13C NMR, including 2D NMR (correlation spectroscopy, heteronuclear multiple bond correlation, and heteronuclear single quantum correlation), and the absolute configuration was compared with that of four synthetic standards produced by solid phase peptide synthesis using a chiral column on a GC–flame ionization detection. This article provides a new method to determine the absolute configuration of cyclo(Pro–Leu) diketopiperazine replacing the joint use of 1H NMR and Marfey’s method.

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Section: Resultsmentioning

confidence: 99%

Diketopiperazines as Cross-Communication Quorum-Sensing Signals between Cronobacter sakazakii and Bacillus cereus

et al. 2017

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“…The consideration of mass resolution, mass accuracy, and chromatographic separation requirements is integral to LC method selection and development. LC is predominantly performed using reversed-phase chromatography (C 18 ,, or C 8 , stationary phases) to separate analytes by increasing hydrophobicity. In addition to the importance of LC in NTA, it is used in the targeted analyses of bisphenols and phthalates with phenyl-hexyl columns as well as the normal phase for antioxidants of interest …”

Section: Chemical Analysismentioning

confidence: 99%

“…The use of complementary (additional) non-MS detectors as part of LC analysis can provide information supportive of structural elucidation and semiquantification of analytes . It is common for LC instruments to be installed with accessories such as diode array detection (DAD) or ultraviolet detection (UV), which perform in-line detection based on optical absorption.…”

Section: Chemical Analysismentioning

confidence: 99%

“…It is common for LC instruments to be installed with accessories such as diode array detection (DAD) or ultraviolet detection (UV), which perform in-line detection based on optical absorption. These detectors are selective for chromophores and are typically not as sensitive as mass spectrometers, though DAD has shown promising reproducibility compared to MS for semiquantification. , For nonchromophores, chemical derivatization approaches are sometimes used to modify the chemical structure with a chromophore to provide a means of quantification (e.g., derivatization of carbonyls). Alternatively, constituents that are not chromophores can be measured by refractive index detection (RID).…”

Section: Chemical Analysismentioning

confidence: 99%

“…RFs are analyte specific and can vary according to the analytical system and workflow, including sample introduction, chromatography, ionization source, and detector. ,, GC/MS and FID methods have relatively low observed variation, and a UF value of 4 has been recommended for those methods . RFs of analytes measured in LC can span a relatively wider range (magnitudes greater than 1000-fold) compared to GC analysis, and for this reason, the assignment of UF for LC/MS analysis can be more challenging. , For example, relative RFs for LC/MS of ∼0.152 to ∼3.367 (23-fold range, negative ionization mode) and ∼0.002 to ∼4.380 (2190-fold range, ionization mode not specified) were reported in two extractable profiling studies. Furthermore, it is worth noting that the selection of surrogate standards and RF databases go hand-in-hand, as UFs are relative to RFs of surrogate standards.…”

Section: Chemical Analysismentioning

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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2022

Extractables and Leachables

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Chromatographic considerations in the standardization of liquid chromatographic methods used for extractables screening

Cited by 16 publications

References 12 publications

Diketopiperazines as Cross-Communication Quorum-Sensing Signals between Cronobacter sakazakii and Bacillus cereus

Diketopiperazines as Cross-Communication Quorum-Sensing Signals between Cronobacter sakazakii and Bacillus cereus

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

Focus on Emerging Concepts

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