Hand Sanitizers
Antiseptics and disinfectants are both designed to kill germs in our everyday lives, however, these two terms should not be used interchangeably. Disinfectants are designed to be used on non-living surfaces while antiseptics are designed to be used on living surfaces such as your hands. When it comes to regulations within the United States, both disinfectants and antiseptics couldn't be any more different.
Disinfectants are regulated by the the United States Environmental Protection Agency (EPA). The EPA regulates disinfectants as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act.
Antiseptics, such as hand sanitizers, are treated as over-the-counter drugs by the FDA since they are intended to prevent illness. Currently, hand sanitizers must comply with GMPs requirements as per 21 CFR 211 and comply with OTC monograph for eligible active ingredients in hand sanitizers.
Our hand sanitizer testing services include both efficacy and ingredient testing.
Typical efficacy services include:
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Minimum inhibitory concentration (MIC)
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Benzalkonium chloride
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Ethyl alcohol or Ethanol (60 to 95 percent)
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Isopropyl alcohol (70 to 91.3 percent
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Standard in vitro time-kill procedure (ASTM E2315)
Our ingredient testing services help identify concentration of active ingredients and impurities. These service include:
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% Ethanol in finished product by gas chromatography
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% IPA in finished product by gas chromatography
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Residual solvents by GC-MS
Some impurities such as methanol can be found in alcohol based hand sanitizers and have lead to recalls due to its toxicity and the risk of accidental ingestion by children.