C6H12O6 180.16

D-Fructose.
D-Fructose [57-48-7].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Fructose RS.

Identification, Infrared Absorption 197K: previously dried.

Color of solution— Dissolve 25 g in water to make 50 mL: the solution has no more color than a solution prepared 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 the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface.

Acidity— Dissolve 5.0 g in 50 mL of carbon dioxide-free water, add phenolphthalein TS, and titrate with 0.02 N sodium hydroxide VS to a distinct pink color: not more than 0.50 mL of 0.02 N sodium hydroxide is required for neutralization.

Loss on drying 731— Dry it in vacuum at 70 for 4 hours: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.5%.

Chloride 221— A 2.0-g portion shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.018%).

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— Prepare a Test Preparation by heating the acidified mixture nearly to dryness and cooling before 30% hydrogen peroxide is added. The limit is 1 ppm.

Calcium and magnesium (as calcium)— Dissolve about 20 g, accurately weighed, in 200 mL of water, and add 2 drops of hydrochloric acid, 5 mL of ammonia–ammonium chloride buffer TS, and 8 drops of eriochrome black TS. Mix, and 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. Not more than 5.0 mL of 0.005 M edetate disodium is consumed (0.005% of Ca).

Heavy metals, Method I 231— Dissolve 4 g in 23 mL of water, and add 2 mL of 1 N acetic acid: the limit is 5 ppm.

Limit of hydroxymethylfurfural— Transfer to a test tube 10 mL of a solution (1 in 10), 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 1 in 100 solution of resorcinol in hydrochloric acid: a slight pink color may develop, but no cherry-red color appears immediately.

Residual solvents 467: meets the requirements.

Assay— Transfer about 10 g of Fructose, previously dried and accurately weighed, to a 100-mL volumetric flask, and dissolve in 50 mL of water. Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. After 30 minutes, 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.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 969

Phone Number : 1-301-816-8143