Alternative and Harmonized Methods and Procedures, may still be considered for use in isopropyl alcohol. The FDA Guidance also states that, “a manufacturer may use an equivalent identification procedure that includes a test to detect and quantify methanol, provided it is validated and fit for such purpose.” We note that if the revisions to the USP Isopropyl Alcohol monograph become official, the test described in the USP Alcohol monograph, if validated according to USP General Notices 6.30. The FDA Guidance includes the recommendation to use the methanol test described in the USP Alcohol monograph to test for methanol contamination in isopropyl alcohol. In addition, it is consistent with the approach for determining methanol and other organic impurities in the USP Alcohol and USP Dehydrated Alcohol monographs. External reference standards will be used instead of the current area normalization approach for quantitative analysis of each individual impurity, including methanol, 1-propanol, acetone, ethyl ether, diisopropyl ether, and 2-butanol.* In general, using external reference standards to quantify the impurities produces more specific and accurate results than using the area normalization procedure.
#Iso propyl alcohol update#
25, 2021, the intent of the proposed revision is also to update the Limit of Volatile Impurities GC method in the USP Isopropyl Alcohol monograph to include methanol in the test. The limit for methanol (200 μL/L) would be the same as that in the USP Alcohol and USP Dehydrated Alcohol monographs, as recommended in the FDA Guidance.Īdditionally, consistent with FDA’s request in a letter on Feb. The added Limit of Methanol test would utilize similar gas-chromatography (GC) conditions to the existing Limit of Volatile Impurities test. The purpose of the proposed revision to the USP Isopropyl Alcohol monograph is to strengthen the Identification (ID) section of the monograph by including a test for Limit of Methanol as an additional Identification C test.
Additional information about this topic can be found in the Frequently Asked Questions for Alcohol and Dehydrated Alcohol. USP previously revised the USP Alcohol and USP Dehydrated Alcohol monographs by including Identification C test for Limit of Methanol. In the recent FDA Guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) (January 2021), FDA also describes its concerns that drug products other than hand sanitizers containing ethanol or isopropyl alcohol, which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. Food and Drug Administration (FDA) on July 30, 2020. This is consistent with a request documented in a letter from the U.S. In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Simple Excipients Expert Committee intends to revise the USP Isopropyl Alcohol monograph by including a Limit of Methanol test in the Identification (ID) section to address the serious public health hazards associated with the use of isopropyl alcohol contaminated with or substituted with methanol. Duplication for commercial use must be authorized in writing by ADAM Health Solutions.Type of Posting: Notice of Intent to Revise Links to other sites are provided for information only - they do not constitute endorsements of those other sites. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition.
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