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Prednisolone Hemisuccinate from Japan

Prednisolone 21-hemisuccinate, succinic acid ester derivative providing water-solubility for IV administration as potent glucocorticoid. Classifies under HTS 2937.21.00.40 as ester of listed prednisolone with Chapter 29 acid-function compound, following ester classification to later numerical heading rule. Used primarily for acute hormone therapy.

Duty Rate — Japan → United States

15%

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
9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter

Import Tips

• Ester linkage verification by HPLC and succinate moiety quantification required

• Lyophilization compatibility data; GMP audit trail for EU/US sites

• Separate from finished lyophilized injections to maintain bulk API status