2023 FDA Science Forum
Headspace GC-MS Methods and Sample Preparation for Hand Sanitizers Liquid, Gel, and Wipe Products: Method Development, Validation, and Application
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
PURPOSE:
To assist the Agency with the hand sanitizer product quality testing, CDER’s OTR s /Division of Product Quality Research developed and validated headspace GC-MS methods to test hand sanitizer products for ethanol, isopropanol, and impurity concentrations. The developed methods were designed to ensure the effectiveness and safety of hand sanitizer products.
METHODS:
Headspace GC-MS methods were developed for the evaluation of alcohol-based hand sanitizer products that include liquid, gel, and wipe formulations. The methods were validated according to ICH Q2 (R1) for specificity, linearity, range, limit of quantitation, accuracy, precision, robustness, spike recovery, and stability for ethanol, isopropanol and 12 impurities. Sample preparation for liquid and gel products consisted of diluting the hand sanitizer products in DMSO for analysis whereas wipe products required a liquid extraction step in DMSO.
RESULTS:
Headspace GC-MS methods for liquid, gel, and wipe hand sanitizer products were each individually 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. All of the tested analytes demonstrated % recovery within the allowable limits (80%-120%). Application of the methods has resulted in the testing of numerous samples collected under a domestic surveillance assignment to monitor product quality.
CONCLUSIONS:
Testing hand sanitizer products provided scientific information to support CDER regulators to take regulatory actions to help to ensure the safety and efficacy of these products for use by the American public.
