Analysis of Impurities in Alcohol-Based Hand Sanitizers by GC-MS

Recently, various types of hand sanitizers have been producedto meet increasing demand due to the spread of infectiousdiseases, and the U.S. Food & Drug Administration (FDA) hasannounced a“Direct Injection Gas Chromatography MassSpectrometry (GC-MS) Method for the Detection of ListedImpurities in Hand Sanitizers”(hereinafter, FDA hand sanitizeranalysis method)for quality assessment of hand sanitizers.Thismethod allows the evaluation of sanitizers with ethanol orisopropanol and can also be used in screening for “listedimpurities” regulated under the FDA’s Guidance for Industry”on alcohol-based hand sanitizer products. Moreover, it is alsopossible to assay for % alcohol under the same analysis conditions as in the impurity analysis.

Content Type:
Application
Document Number:
M315
Product Type:
Gas Chromatograph-Mass Spectrometry
Keywords:
Pharmaceutical, Life Science
Language:
English

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For Research Use Only. Not for use in diagnostic procedures.

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