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查找USP33结晶果糖标准 已有1人参与
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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 |
2楼2014-01-03 12:41:21
