Qualitative assessment of extractables from single-use components and the impact of reference standard selection

Jordi, Mark Anderson; Khera, S.; Roland, Kevin; Jiang, Liuwei; Solomon, Paige; Nelson, Jenny; Lateef, Syed Salman; Woods, James S.; Martin, L. J.; Martin, Samantha; Aiello, Frankie; Chen, Nina

doi:10.1016/j.jpba.2017.12.029

Cited by 23 publications

(19 citation statements)

References 14 publications

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Section: Applications Of Mass Spectrometrymentioning

confidence: 99%

“…Jordi et al () described the impact of reference standard selection used for extractables from single‐use components, analyzed by HPLC‐MS. Their research nicely illustrates how the number of components above the AET can differ drastically based on the reference standards used to generate the AET.…”

Section: Applications Of Mass Spectrometrymentioning

confidence: 99%

“…This review will focus on the use of mass spectrometers and other detectors for quantification. There are many publications that discuss the use of a suite of compounds that try to cover a range of different chemical classes to quantify all components from an extract solution (Jenke, 2012;Jordi et al, 2018). Jenke and Odufu (2012) detailed an approach with response factors for eight internal standards to quantify 38 leachable compounds from a pharmaceutical packaging system with GC-FID and GC-MS. From this research, they noted the need for caution when they quantified acidic and basic compounds because their responses were different from neutral compounds.…”

Section: Quantificationmentioning

confidence: 99%

“…Although there is some variation in instrument response for different chemicals, GC with EI-MS detection does not suffer the large variability in ionization that HPLC-ESI-MS platforms have, due to suppression and ionization/volatilization efficiency differences. Jordi et al (2018) described the impact of reference standard selection used for extractables from single-use components, analyzed by HPLC-MS. Their research nicely illustrates how the number of components above the AET can differ drastically based on the reference standards used to generate the AET. Their data, Table 2, illustrated how different numbers of unknown constituents would be above the AET based on which standard RRF was used to generate the AET.…”

Section: Quantificationmentioning

confidence: 99%

“…Differential Analysis Results for HPLC/Q-TOF. Reprinted with permission from Jordi et al (2018), copyright year 2017 (Elsevier). quantification were seven BPS and DHBP monomer derivatives.…”

Section: Quantificationmentioning

confidence: 99%

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The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals

Sica

Krivos

Kiehl

et al. 2019

Mass Spectrometry Reviews

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In addition to degradation products, impurities, and exogenous contaminants, industries such as pharmaceutical, food, and others must concern themselves with leachables. These chemicals can derive from containers and closures or migrate from labels or secondary containers and packaging to make their way into products. Identification and quantification of extractables (potential leachables) and leachables, typically trace level analytes, is a regulatory expectation intended to ensure consumer safety and product fidelity. Mass spectrometry and related techniques have played a significant role in the analysis of extractables and leachables (E&L). This review provides an overview of how mass spectrometry is used for E&L studies, primarily in the context of the pharmaceutical industry. This review includes work flows, examples of how identification and quantification is done, and the importance of orthogonal data from several different detectors. E&L analyses are driven by the need for consumer safety. These studies are expected to expand in existing areas (e.g., food, textiles, toys, etc.) and into new, currently unregulated product areas. Thus, this topic is of interest to audiences beyond just the pharmaceutical and health care industries. Finally, the potential of universal detector approaches used in other areas is suggested as an opportunity to drive E&L research progress in this arguably understudied, under‐published realm.

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Section: Applications Of Mass Spectrometrymentioning

confidence: 99%

Section: Applications Of Mass Spectrometrymentioning

confidence: 99%

Section: Quantificationmentioning

confidence: 99%

Section: Quantificationmentioning

confidence: 99%

Section: Quantificationmentioning

confidence: 99%

See 3 more Smart Citations

The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals

Sica

Krivos

Kiehl

et al. 2019

Mass Spectrometry Reviews

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Applications – Pharmaceutical Drug Products – Manufacturing Components and Systems

2022

Extractables and Leachables

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Study of extractables and leachables of non‐polyvinyl chloride soft infusion bags from different batches by analytical assessment threshold screening

Lu,

Sun,

Debraha

et al. 2023

Packag Technol Sci

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This study utilized ultra‐high‐performance liquid chromatography combined with quadrupole time‐of‐flight mass spectrometry and gas chromatography–mass spectrometry techniques to analyze multiple batches of non‐polyvinyl chloride (PVC) soft bags exposed to three extractants. Based on an established library of relative response factors for more than 30 different polymer additives, analytical evaluation thresholds for large volume injectables were determined, and 30 extractables were screened and (semi‐)quantitatively analyzed. To identify variations in extractables between batches, multivariate statistical methods such as principal component analysis, heat map analysis, and hierarchical cluster analysis were employed. Additionally, a comprehensive risk assessment of extractables and a biosafety assessment of leachables were conducted. The results of the study revealed that the concentrations of two extractables exceeded the established safety threshold. Moreover, one of these extractables was deemed to pose a mutagenic risk based on the consistent findings of two (Q)SAR software tools. Notably, certain extractables exhibited discrepancies in their content between batches, with particular emphasis on 1,3‐bis(3,5‐di‐tert‐butyl‐4‐hydroxybenzyl)‐1,3,5‐triazinane‐2,4,6‐trione. This discrepancy led to inconsistencies in risk levels across batches. However, the levels of leachables detected in the non‐PVC soft bags were found to be within the safety threshold, and cytotoxicity assessments consistently yielded negative results for leachables. Consequently, this study provides valuable data for conducting batch stability investigations concerning extractables in large volume parenteral drug delivery containers and other forms of pharmaceutical packaging.

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Qualitative assessment of extractables from single-use components and the impact of reference standard selection

Cited by 23 publications

References 14 publications

The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals

The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals

Applications – Pharmaceutical Drug Products – Manufacturing Components and Systems

Study of extractables and leachables of non‐polyvinyl chloride soft infusion bags from different batches by analytical assessment threshold screening

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