Proposed USP Methanol ID testing for USP Alcohols

Proposed USP Methanol Identification Testing for Alcohol, Isopropyl Alcohol and Related USP/NF monographs

Avantor Product Scope: Panoli, India, Paris, KY USA, and Phillipsburg, NJ USA released finished goods

Dear Valued Customer,

On July 30, 2020, the United States FDA issued a letter (REF: 07-20-037-N) indicating discussion with the United Stated Pharmacopeia to include a test for methanol in the “Identification” section of Alcohol, Isopropyl Alcohol and any related USP/NF monographs to help prevent methanol contamination. FDA recommends keeping the methanol limit already required in the Organic Impurities test of USP Alcohol and Dehydrated Alcohol monographs. In response, USP issued a Notice of Intent to Revise on July 31, 2020, to add a Limit of Methanol test to the USP Alcohol and USP Dehydrated Alcohol monographs in the Identification section that references methanol in the Organic Impurities test in the monographs. The Revision Bulletin was released August 17, 2020, and will become official September 1, 2020.

• Since USP compliant Alcohol (Ethanol) and Dehydrated Alcohol (Ethanol) are not marketed by Avantor nor used in manufacturing any of our products released from the above plants, no impact is expected from the proposed requirement change.
• Avantor does market USP Isopropyl Alcohol.  Currently, there is no requirement in the USP monograph to determine methanol content as an impurity.  Once an Identification test for methanol content is added to the USP Isopropyl Alcohol monograph, Avantor will fully comply with the requirement. 
• Since Avantor does not use USP Isopropyl Alcohol in the manufacturing of other products, there is no other impact from the proposed monograph revision other than to our marketed USP Isopropyl Alcohol products.

Avantor will continue to monitor and evaluate the potential impact to all of our products from this and any future USP revisions.
UPDATE: March 15, 2021:

The US Food and Drug Administration issued the guidance “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)” in January, 2021.  Although the guidance places the responsibility on the drug manufacturer of assuring the absence of methanol in their isopropyl alcohol supply (FDA indicates <200 ppm ethanol as acceptable),  Avantor  is providing this notice for all USP compliant Isopropyl Alcohol product codes we market in the United States.  At this time, pending revision of the USP monograph for Isopropyl Alcohol, Avantor is not testing USP Isopropyl Alcohol packaged at our US facilities and has determined the risk of methanol as an impurity in the product to be low:

• Our source of bulk USP Isopropyl Alcohol is by direct shipment from our sole US based qualified GMP supplier.
• All US released Avantor USP Isopropyl Alcohol is  repackaged as required by Avantor under current GMPs. 
• Our supplier monitors impurities in their production, and claim methanol is not present as a manufacturing impurity, and no methanol is intentionally added by either the manufacturer or Avantor.

Avantor will comply with any USP Isopropyl Alcohol monograph revision for the determination of methanol as an impurity, when official.

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