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HQ 963287

April 17, 2001

CLA-2 RR:CR:GC 963287 AM


TARIFF NO.: 2940.00.60

Mr. John W. Whitaker
O'Neill & Whitaker, Inc.
1809 Baltimore Ave.
Kansas City, MO 64108

RE: NY B89369 revoked; sulfobutylether ß-cyclodextrin (Captisol™).

Dear Mr. Whitaker:

This is in reference to a New York Ruling Letter (NY) B89369 issued to you, on behalf of Cydex, Inc., on November 25, 1997, by the Director, Customs National Commodity Specialist Division, New York, concerning the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of sulfobutylether ß-cyclodextrin, also known as Captisol™. In NY B89369, this product was classified in subheading 3505.10.00, HTSUS, which provides for "[D]extrins and other modified starches (for example, pregelatinized or esterified starches); glues based on starches, or on dextrins or other modified starches: [D]extrins and other modified starches."

After careful review by this office, we have determined that the classification set forth in NY B89369 for sulfobutylether ß-cyclodextrin is in error. This ruling revokes NY B89369.

Pursuant to section 625(c)(1) Tariff Act of 1930 (19 U.S.C. 1625(c)(1)) as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act, (Pub. L. 103-82, 107 Stat. 2057, 2186), notice of the proposed revocation of NY B89369 was published on March 14, 2001, in the CUSTOMS BULLETIN, Volume 35, Number 11. No comments were received in response to this notice.


Sulfobutylether ß-cyclodextrin has the following molecular formula: C42H70-nO35(C4H8SO3Na)n; where n = the average degree of substitution. The substance is assigned CAS registry number 182410-00-0 (previously assigned CAS # 7585-39-9D). During the synthesis of this substance, 1,4-butane sultone reacts with any of three hydroxyl groups on each of the seven glucopyranose units of the ß-cyclodextrin molecule. The resulting material is a composite mixture having an average degree of substitution of seven. Sulfobutylether ß-cyclodextrin is marketed as Captisol™ which enhances water solubility of other compounds used in the administration of intravenous, intraocular, intramuscular and oral pharmaceuticals so as to decrease local and systemic irritation and reaction in the patient.


Whether sulfobutylether ß-cyclodextrin is classified in heading 2940, HTSUS, as ". . . sugar ethers and sugar esters, and their salts, . . .", or in heading 3505, HTSUS, as "[D]extrins and other modified starches".


Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law.

GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs. In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are generally indicative of the proper interpretation of the HTSUS. See T.D. 8980, 54 Fed. Reg. 35127 (August 23, 1989).

The following HTSUS headings are relevant to the classification of this product:

2940.00 Sugars, chemically pure, other than sucrose, lactose, maltose, glucose and fructose; sugar ethers and sugar esters, and their salts, other than products of heading 2937, 2938 or 2939:

Dextrins and other modified starches (for example, pregelatinized or esterified starches); glues based on starches, or on dextrins or other modified starches:

The Chapter Notes to Chapter 29 state, in pertinent part, as follows:

Except where the context otherwise requires, the headings of this chapter apply only to:

Separate chemically defined organic compounds, whether or not containing impurities;

Mixtures of two or more isomers of the same organic compound (whether or not containing impurities), except mixtures of acyclic hydrocarbon isomers (other than stereoisomers), whether or not saturated (chapter 27); . . .

The products of headings Nos. 29.36 to 29.39 or the sugar ethers and sugar esters, and their salts, of heading No. 29.40, or the products of heading No. 29.41, whether or not chemically defined;

In NY B89369 this merchandise was incorrectly classified in heading 3505, HTSUS, as a modified starch possibly because the word "dextrin", incorporated into its name, is eo nomine provided for in the heading. However, ß-cyclodextrin, the parent molecule of the instant substance, is a sugar of heading 2940, HTSUS, not a dextrin or other modified starch. Thus, ß-cyclodextrin is not described in heading 3505, HTSUS. (See New York Ruling Letter B80145, dated January 28, 1997. See also Headquarters Ruling Letter 955089, dated February 15, 1994).

In the instant product, sulfobutylether ß-cyclodextrin, the introduction of the sulfobutyl functionality at one or more of the glucopyranose units in the ß-cyclodextrin structure creates ether linkages at the 2, 3, and 6 positions. Since the parent molecule, ß-cyclodextrin, is a cyclic oligosaccaride, which qualifies as a sugar, creation of ether linkages by the addition of the sulfobutyl groups makes the instant product a sugar ether of heading 2940, HTSUS.

Although the addition of the sulfobutylether functionality in the instant product creates a molecule that is not a "separately defined organic compound" or "a mixture of two or more isomers of the same organic compound," it is a sugar ether of heading 2940 and therefore remains classified in Chapter 29 by action of chapter note 1(c), above.


Sulfobutylether ß-cyclodextrin is classified in subheading 2940.00.60, HTSUS, as "[S]ugars, chemically pure, other than sucrose, lactose, maltose, glucose and fructose; sugar ethers and sugar esters, and their salts, other than products of heading 2937, 2938 or 2939: [O]ther."


NY B89369 is revoked.

In accordance with 19 U.S.C. §1625(c)(1), this ruling will become effective 60 days after its publication in the CUSTOMS BULLETIN.


John Durant, Director
Commercial Rulings Division

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