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Application of a headspace GC–MS method to evaluate the product quality of alcohol‐based hand wipe sanitizers

Journal Article · · BMC Biomedical Chromatography
DOI:https://doi.org/10.1002/bmc.5432· OSTI ID:2425587
 [1];  [2];  [1];  [3];  [3];  [1];  [1]
  1. Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, Division of Product Quality Research Food and Drug Administration Silver Spring MD USA
  2. Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, Division of Pharmaceutical Analysis Food and Drug Administration St Louis MO USA
  3. Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Quality Surveillance, Division of Quality Intelligence II Food and Drug Administration Silver Spring MD USA
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Abstract

The investigation of marketed hand wipe sanitizers presented an analytical challenge owing to the need for extraction from the solid matrix of the products. The present work describes the development of a new sample preparation method for the extraction of analytes from the hand wipe sanitizer matrix into dimethyl sulfoxide for analysis using headspace GCMS. Alcohol‐based hand sanitizer (ABHS) wipe products labeled to contain ethanol or isopropanol as active ingredients were tested, varying in the size and weight of the wipes. The spike recovery assay was confirmed using spiking solutions containing impurities at concentrations equivalent to 50, 100 and 200% of the interim concentration limits. All of the tested analytes showed recovery within the allowable limits (80–120%). Six marketed ABHS wipe products were tested and no impurities above the FDA interim limits were observed. One product contained ethanol below the 60% v/v limit and another product was mislabeled for isopropanol and was found to contain ethanol instead. Four of the six ABHS products did not meet the label claim, which may affect the product quality. The analytical method and sample preparation procedures will provide the FDA and ABHS manufacturers with the capability to conduct quality assurance testing of hand wipe sanitizers for active ingredient content and impurities.

Research Organization:
Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
Sponsoring Organization:
USDOE Office of Science (SC)
DOE Contract Number:
SC0014664
OSTI ID:
2425587
Journal Information:
BMC Biomedical Chromatography, Journal Name: BMC Biomedical Chromatography Journal Issue: 10 Vol. 36; ISSN 0269-3879
Publisher:
BioMed Central
Country of Publication:
United States
Language:
English

References (9)

Designing an ideal alcohol-based hand sanitizer: in vitro antibacterial responses of ethanol and isopropyl alcohol solutions to changing composition journal November 2021
Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers journal January 2022
Sampling and Analytical Method Development and Hand Wipe Measurements of Dermal Exposures to Polycyclic Aromatic Hydrocarbons journal May 2008
Through-container quantitative analysis of hand sanitizers using spatially offset Raman spectroscopy journal September 2021
Monitoring the quality of ethanol-based hand sanitizers by low-cost near-infrared spectroscopy journal December 2020
Analysis of alcohol-based hand sanitizer delivery systems: Efficacy of foam, gel, and wipes against influenza A (H1N1) virus on hands journal November 2012
A fast and low-cost approach to quality control of alcohol-based hand sanitizer using a portable near infrared spectrometer and chemometrics journal March 2021
Alcohol-based hand sanitisers as first line of defence against SARS-CoV-2: a review of biology, chemistry and formulations journal January 2020
Hand sanitizers: A review of ingredients, mechanisms of action, modes of delivery, and efficacy against coronaviruses journal September 2020

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