Noncrystallizing Sorbitol Solution
»Noncrystallizing Sorbitol Solution is an aqueous solution containing not less than 45.0percent of D-sorbitol (C6H14O6)(w/w).The amounts of total sugars,other polyhydric alcohols,and any hexitol anhydrides,if detected,are not included in the requirements nor in the calculated amount under Other Impurities.
Packaging and storage— Preserve in well-closed containers.Do not store below 20.
Identification—
A: Dissolve 1.4g of Noncrystallizing Sorbitol Solution in 75mLof water.Transfer 3mLof this solution to a 15-cm test tube,add 3mLof freshly prepared catechol solution (1in 10),mix,add 6mLof sulfuric acid,mix again,and gently heat the tube in a flame for about 30seconds:a deep pink or wine-red color appears.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Microbial limits á61ñ— The total aerobic microbial count using thePlate Method is not more than 1000cfu per mL,and the total combined molds and yeasts count is not more than 100cfu per mL.
pHá791ñ: between 5.0and 7.5,in a 14%(w/w)solution of Noncrystallizing Sorbitol Solution in carbon dioxide-free water.
Water,Method Iá921ñ: between 28.5%and 31.5%.
Residue on ignition á281ñ: not more than 0.1%,calculated on the anhydrous basis,determined on a 2-g portion,accurately weighed.
Reducing sugars— To an amount of Noncrystallizing Sorbitol Solution,equivalent to 3.3g on the anhydrous basis,add 3mLof water,20.0mLof cupric citrate TS,and a few glass beads.Heat so that boiling begins after 4minutes,and maintain boiling for 3minutes.Cool rapidly,and add 40mLof diluted acetic acid,60mLof water,and 20.0mLof 0.05Niodine VS.With continuous shaking,add 25mLof a mixture of 6mLof hydrochloric acid and 94mLof water.When the precipitate has dissolved,titrate the excess of iodine with 0.05Nsodium thiosulfate VSusing 2mLof starch TS,added towards the end of the titration,as an indicator.Not less than 12.8mLof 0.05Nsodium thiosulfate VSis required,corresponding to not more than 0.3%of reducing sugars,on the anhydrous basis,as glucose.The amount determined in this test is not included in the calculated amount underOther Impurities.
Limit of nickel— Proceed as directed in the test forLimit of nickel underSorbitol Solution.Not more than 1µg per g,calculated on the anhydrous basis,is found.
Assay—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in theAssay underSorbitol.
Assay preparation— Accurately weigh about 0.20g of Noncrystallizing Sorbitol Solution,and dissolve in and dilute with water to about 20g.Accurately record the final solution weight,and mix thoroughly.
Procedure— Proceed as directed in theAssay underSorbitol.Calculate the percentage of D-sorbitol (C6H14O6)in the portion of Noncrystallizing Sorbitol Solution taken by the formula:
100(CS/CU)(rU/rS),
in whichCSis the concentration,in mg per g,of USP Sorbitol RSin theStandard preparation;CUis the concentration,in mg per g,of Noncrystallizing Sorbitol Solution in theAssay preparation;and rUand rSare the peak responses obtained from theAssay preparation and theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3086
Pharmacopeial Forum:Volume No.30(3)Page 995
Phone Number:1-301-816-8262