C12H22O11 342.30

a-D-Glucopyranoside,b-D-fructofuranosyl-.
Sucrose [57-50-1].

Packaging and storage— Preserve in well-closed containers.

Specific rotation á781Sñ: not less than +65.9.

Residue on ignition á281ñ: not more than 0.05%,a 5-g specimen being used.

Chloride á221ñ— A2.0-g portion shows no more chloride than corresponds to 0.10mLof 0.020Nhydrochloric acid (0.0035%).

Sulfate á221ñ— A5.0-g portion shows no more sulfate than corresponds to 0.30mLof 0.020Nsulfuric acid (0.006%).

Calcium— To 10mLof a solution (1in 10)add 1mLof ammonium oxalate TS:the solution remains clear for at least 1minute.

Heavy metals á231ñ— Dissolve 4.0g in 15mLof water,add 1mLof 0.12Nhydrochloric acid,and dilute with water to 25mL:the limit is 5ppm.

Invert sugar— Dissolve 20g in water to make 100mL,and filter if necessary.Place 50mLof the clear liquid in a 250-mLbeaker,add 50mLof alkaline cupric tartrate TS,cover the beaker with a watch glass,and heat the mixture at such a rate that it comes to a boil in approximately 4minutes,and boil for 2minutes,accurately timed.Add at once 100mLof cold,recently boiled water,and immediately collect the precipitated cuprous oxide on a tared filtering crucible containing a sintered-glass disk of medium pore size,or suitable equivalent.Thoroughly wash the residue on the filter with hot water,then with 10mLof alcohol,and finally with 10mLof ether,and dry at 105for 1hour:the weight of the cuprous oxide does not exceed 112mg.

Organic volatile impurities,Method IVá467ñ: meets the requirements.

Expert Committee:(EMC)Excipients:Monograph Content

USP28–NF23Page 3094

Phone Number:1-301-816-8323