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pipi9888: 金幣+2, ★有幫助 2014-01-08 15:27:57

Fructose
(fruk' tose; frook' tose)
C6H12O6
180.16
D-Fructose;
D-Arabino-hex-2-ulose;
D-Levulose [57-48-7].
DEFINITION
Fructose, dried in vacuum at 70 for 4 h, contains NLT 98.0% and NMT 102.0% of
C6H12O6.
IDENTIFICATION
• INFRARED ABSORPTION 197K : Previously dried
ASSAY
• PROCEDURE
Sample solution: Transfer 10 g of Fructose, previously dried, to a 100–mL volumetric
flask, and dissolve in 50 mL of water. Add 0.2 mL of 6 N ammonium hydroxide, and
dilute with water to volume.
Analysis: After 30 min, determine the angular rotation in a 100-mm tube at 25 (see
Optical Rotation 781 ). The observed rotation, in degrees, multiplied by 1.124,
represents the weight, in g, of C6H12O6 in the Fructose taken.
Acceptance criteria: 98.0%–102.0% on a previously dried basis
IMPURITIES
Inorganic Impurities
• RESIDUE ON IGNITION 281 : NMT 0.5%
• CHLORIDE AND SULFATE, Chloride 221 : A 2.0-g portion shows no more chloride than
© 2009 USPC Official 5/1/10 - 7/31/10 USP Monographs: Fructose 1/3
Create PmDkF:@ fileMs SwIiTthSotuot rteh:iCs :m\Uesssearsg\eg rb\yD peusrkcthoaps\iunsgp n3o3v\auPspD3F3 p_rninft2e8r \(uhsttpp3:/3/w_wnfw2.8no.cvhampd:f:./cuosmpn) f/pub/... 2014/1/3
corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.018%).
• CHLORIDE AND SULFATE, Sulfate 221 : A 2.0-g portion shows no more sulfate than
corresponds to 0.50 mL of 0.020 N sulfuric acid (0.025%).
• ARSENIC, Method II 211
Sample solution: Prepare by heating the acidified mixture nearly to dryness, cooling,
and adding 30% hydrogen peroxide.
Acceptance criteria: NMT 1 ppm
• CALCIUM AND MAGNESIUM (AS CALCIUM)
Sample solution: Dissolve 20 g in 200 mL of water; add 2 drops of hydrochloric acid,
5 mL of ammonia-ammonium chloride buffer TS, and 8 drops of eriochrome black
TS; and mix.
Analysis: Titrate with 0.005 M edetate disodium VS to a blue endpoint. Each mL of
0.005 M edetate disodium is equivalent to 200.4 μg of Ca.
Acceptance criteria: NMT 5.0 mL of 0.005 M edetate disodium is consumed (0.005%
of Ca).
• HEAVY METALS, Method I 231
Sample solution: 4 g in 23 mL of water; add 2 mL of 1 N acetic acid
Acceptance criteria: NMT 5 ppm
Organic Impurities
• PROCEDURE: LIMIT OF HYDROXYMETHYLFURFURAL
Sample solution: 100 mg/mL in water
Analysis: To 10 mL of Sample solution, add 5 mL of ether, and shake vigorously.
Transfer 2 mL of the ether layer to a test tube, and add 1 mL of a 10 mg/mL solution
of resorcinol in hydrochloric acid.
Acceptance criteria: A slight pink color may develop, but no cherry-red color appears
immediately.
SPECIFIC TESTS
• COLOR OF SOLUTION
Sample solution: Dissolve 25 g in water to make 50 mL.
Analysis: Prepare a comparison solution by mixing 1.0 mL of cobaltous chloride CS,
3.0 mL of ferric chloride CS, and 2.0 mL of cupric sulfate CS with water to make 10
mL, and diluting 3 mL of this solution with water to make 50 mL. Make a comparison
by viewing the two solutions downward in matched color-comparison tubes against a
white surface.
Acceptance criteria: The Sample solution has no more color than the comparison
solution.
• ACIDITY
Sample solution: Dissolve 5.0 g in 50 mL of carbon dioxide-free water, and add
phenolphthalein TS.
© 2009 USPC Official 5/1/10 - 7/31/10 USP Monographs: Fructose 2/3
Create PmDkF:@ fileMs SwIiTthSotuot rteh:iCs :m\Uesssearsg\eg rb\yD peusrkcthoaps\iunsgp n3o3v\auPspD3F3 p_rninft2e8r \(uhsttpp3:/3/w_wnfw2.8no.cvhampd:f:./cuosmpn) f/pub/... 2014/1/3
Analysis: Titrate with 0.02 N sodium hydroxide VS to a distinct pink color.
Acceptance criteria: NMT 0.50 mL of 0.02 N sodium hydroxide is required for
neutralization.
• LOSS ON DRYING 731 : Dry in vacuum at 70 for 4 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers.
• USP REFERENCE STANDARDS 11
USP Fructose RS
Auxiliary Information— Please check for your question in the FAQs before contacting
USP.
USP33–NF28 Page 3186
Pharmacopeial Forum: Volume No. 29(5) Page 1496
Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientist
1-301-998-6828
(MDPS05) Monograph Development-
Pulmonary and Steroids
Reference
Standards
Lili Wang, Technical
Services Scientist
1-301-816-8129
RSTech@usp.org
© 2009 USPC Official 5/1/10 - 7/31/10 USP Monographs: Fructose 3/3
Create PmDkF:@ fileMs SwIiTthSotuot rteh:iCs :m\Uesssearsg\eg rb\yD peusrkcthoaps\iunsgp n3o3v\auPspD3F3 p_rninft2e8r \(uhsttpp3:/3/w_wnfw2.8no.cvhampd:f:./cuosmpn) f/pub/... 2014/1/3

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