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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2019]
[CITE: 21CFR168.111]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 168 -- SWEETENERS AND TABLE SIRUPS

Subpart B--Requirements for Specific Standardized Sweeteners and Table Sirups

Sec. 168.111 Dextrose monohydrate.

(a) Dextrose monohydrate is purified and crystallized D-glucose containing one molecule of water of crystallization with each molecule of D-glucose.

(b) The food shall meet the following specifications:

(1) The total solids content is not less than 90.0 percent mass/mass (m/m), and the reducing sugar content (dextrose equivalent), expressed as D-glucose, is not less than 99.5 percent m/m calculated on a dry basis.

(2) The sulfated ash content is not more than 0.25 percent m/m (calculated on a dry basis), and the sulfur dioxide content is not more than 20 mg/kg.

(c) The name of the food is "Dextrose monohydrate" or "Dextrose" or alternatively, "___ sugar monohydrate" or "___ sugar", with the blank to be filled with the name of the food source, for example, "Corn sugar monohydrate" or "Corn sugar".

(d) For purposes of this section, the methods of analysis to be used to determine if the food meets the specifications of paragraph (b) (1) and (2) of this section are the following sections in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.

(1) Total solids content, 31.005.

(2) Reducing sugar content, section 31.220(a).

(3) Sulfated ash content, section 31.216.

(4) Sulfur dioxide content, sections 20.106-20.111.

[42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998]

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