C6H12O6 180.16

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

Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Fructose RS.

Identification,Infrared Absorption á197Kñ: previously dried.

Color of solution— Dissolve 25g in water to make 50mL:the solution has no more color than a solution prepared by mixing 1.0mLof cobaltous chloride CS,3.0mLof ferric chloride CS,and 2.0mLof cupric sulfate CSwith water to make 10mL,and diluting 3mLof this solution with water to make 50mL.Make the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface.

Acidity— Dissolve 5.0g in 50mLof carbon dioxide-free water,add phenolphthalein TS,and titrate with 0.02Nsodium hydroxide VSto a distinct pink color:not more than 0.50mLof 0.02Nsodium hydroxide is required for neutralization.

Loss on drying á731ñ— Dry it in vacuum at 70for 4hours:it loses not more than 0.5%of its weight.

Residue on ignition á281ñ: not more than 0.5%.

Chloride á221ñ— A2.0-g portion shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid (0.018%).

Sulfate á221ñ— A2.0-g portion shows no more sulfate than corresponds to 0.50mLof 0.020Nsulfuric acid (0.025%).

Arsenic,Method IIá211ñ— Prepare a Test Preparationby heating the acidified mixture nearly to dryness and cooling before 30%hydrogen peroxide is added.The limit is 1ppm.

Calcium and magnesium (as calcium)— Dissolve about 20g,accurately weighed,in 200mLof water,and add 2drops of hydrochloric acid,5mLof ammonia–ammonium chloride buffer TS,and 8drops of eriochrome black TS.Mix,and titrate with 0.005Medetate disodium VSto a blue endpoint.Each mLof 0.005Medetate disodium is equivalent to 200.4µg of Ca.Not more than 5.0mLof 0.005Medetate disodium is consumed (0.005%of Ca).

Heavy metals,Method Iá231ñ— Dissolve 4g in 23mLof water,and add 2mLof 1Nacetic acid:the limit is 5ppm.

Limit of hydroxymethylfurfural— Transfer to a test tube 10mLof a solution (1in 10),add 5mLof ether,and shake vigorously.Transfer 2mLof the ether layer to a test tube,and add 1mLof a 1in 100solution of resorcinol in hydrochloric acid:a slight pink color may develop,but no cherry-red color appears immediately.

Assay— Transfer about 10g of Fructose,previously dried and accurately weighed,to a 100-mLvolumetric flask,and dissolve in 50mLof water.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.After 30minutes,determine the angular rotation in a 100-mm tube at 25(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by -1.124,represents the weight,in g,of C6H12O6in the Fructose taken.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 873

Phone Number:1-301-816-8379