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


User Benefits

・This method can quantify impurities and alcohol (ethanol or isopropanol) in hand sanitizers. ・It is possible to measure listed impurities in a wide range of concentrations from low to high under a single analysis condition. ・FASST (Fast Automated Scan/SIM Type) analysis can identify compounds other than the listed impurities in hand sanitizers.


Recently, various types of hand sanitizers have been produced to meet increasing demand due to the spread of infectious diseases, and the U.S. Food & Drug Administration (FDA) has announced a “Direct Injection Gas Chromatography Mass Spectrometry (GC-MS) Method for the Detection of Listed Impurities in Hand Sanitizers” (hereinafter, FDA hand sanitizer analysis method) for quality assessment of hand sanitizers. This method allows the evaluation of sanitizers with ethanol or isopropanol and can also be used in screening for “listed impurities” regulated under the FDA’s “Guidance for Industry” on alcohol-based hand sanitizer products. Moreover, it is also possible to assay for % alcohol under the same analysis conditions as in the impurity analysis. In this article, the quantitative analysis of impurities and alcohol concentration in ethanol-based sanitizers was conducted using a Shimadzu GCMS-QP2020 NX single quadrupole GC-MS, referring to the FDA hand sanitizer analysis method. The analysis conditions described in this article can be used to measure impurity and alcohol concentration in alcohol-based sanitizers. Furthermore, the listed impurities can be detected over a wide concentration range, and the system requirements were satisfied. It is also possible to identify compounds other than the listed impurities by a FASST analysis using high speed switching between the Scan mode and the SIM mode.

January 14, 2024 GMT