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Pharma-Grade Potassium Sorbate USP from Japan

USP-grade potassium sorbate meeting United States Pharmacopeia standards for pharmaceutical applications, classified under HTS 2916.19.10.00. As a chemically defined salt of sorbic acid, it serves as an antimicrobial preservative in liquid medications and syrups. Chapter notes confirm classification for pure compounds with stabilizers for safety/transport.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

File Drug Master File (DMF) with FDA and provide USP certificate of analysis

Ensure compliance with 21 CFR 184.1854 for GRAS status in drugs

Pitfall: incorrect pharma vs food grade declaration affects bonding requirements