Pharmaceutical Lidocaine HCL Monohydrate from Japan
Lidocaine hydrochloride monohydrate USP/EP grade, containing one water molecule per API unit, used in sustained-release formulations. Specific HTS 2924.29.57.00 classification for this aromatic amide salt per Chapter 29 note on organic salts. White crystalline powder soluble in water for aqueous injections.
Duty Rate — Japan → United States
27.5%
Rate breakdown
9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
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
• Document water content (4.7-5.5%) via Karl Fischer titration to confirm monohydrate form vs anhydrous
• Provide polymorphic form characterization (DSC/XRD) if patent-protected to avoid infringement issues
• Maintain humidity-controlled packaging (<40% RH) during ocean freight to prevent hydrate conversion