PURPOSE: The COVID-19 pandemic has increased the demand of hand sanitizer products by the public. The FDA has published a temporary guidance for industry detailing the preparation of alcohol-based hand sanitizer products at the request of drug manufacturers. To assist the Agency with the hand sanitizer product quality testing, CDER Laboratories developed and validated headspace GC-MS methods to test hand sanitizer products for ethanol, isopropanol, and impurity concentrations. METHODS: Headspace GC-MS methods were developed for alcohol-based hand sanitizer products in complex matrices. The methods were validated according to ICH Q2 (R1) for specificity, linearity, range, limit of quantitation, accuracy, precision, robustness. Spike recovery and stability studies were conducted. Ethanol and isopropanol and 12 impurities (methanol, benzene, acetaldehyde, acetal, acetone, 1-propanol, ethyl acetate, 2-butanol, Isobutanol, 1-butanol, 3-methyl-1-butanol, and amyl alcohol) were evaluated using the respective the headspace GC-MS methods. Sample preparation was dependent on the hand sanitizer matrix with wipes requiring a liquid extraction step in dimethyl sulfoxide, while other liquid and gel matrices were simply diluted in DMSO. A calibration curve was used for determining the concentration of analytes based on the relative response of analyte to internal standard. Spike recovery in hand sanitizers was within the specification of 80-120% recovery for all analytes at three different spiking concentrations and precision was below 10% for samples in triplicate. RESULTS: Three headspace GC-MS methods for hand sanitizer products were successfully validated according to the ICH Q2 (R1) guidelines and passed all the set criteria. All validated analytes maintained their reported linearity with coefficients of determination (R2) greater than 0.99. Inter-day percent accuracy and precision of the tested analytes for the four levels all met the specifications within 80-120% accuracy and ≤ 5% RSD. The tested analytes demonstrated % recovery within the allowable limits (80%-120%). Application of the methods has resulted in the testing of hand sanitizer products to assist the FDA with monitoring the product quality of marketed hand sanitizers. CONCLUSIONS:The developed analytical methods provided CDER regulators with scientific data that assisted with regulatory actions, helping to best ensure the safety and efficacy of hand sanitizer products for use by the American public.

Development of analytical methods for hand sanitizer OTC products: Regulatory considerations for safety and product quality

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