Maltitol Solution
»Maltitol Solution is a water solution containing,on the anhydrous basis,not less than 50.0percent of D-maltitol (C12H24O11)(w/w),and not more than 8.0percent of D-sorbitol (C6H14O6)(w/w).The amounts of total sugars,other polyhydric alcohols,and any polyol 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 Maltitol Solution in 75mLof water.Transfer 3mLof this solution to a 15-cm test tube,add 3mLof freshly prepared catechol solution (1in 10),and mix.Add 6mLof sulfuric acid,mix,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 Maltitol Solution in carbon dioxide-free water.
Water,Method Iá921ñ: not more than 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 Maltitol 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— Use degassed water.
Standard preparation— Dissolve accurately weighed quantities of USP Maltitol RSand USP Sorbitol RSin water to obtain a solution having known concentrations of about 10mg per g and 1.6mg per g,respectively.
Assay preparation— Accurately weigh about 0.4g of Maltitol Solution,and dissolve in and dilute with water to about 20g.Accurately record the final solution weight,and mix thoroughly.
Chromatographic system(seeChromatography á621ñ)— The liquid chromatograph is equipped with a refractive index detector that is maintained at a constant temperature of about 35and a 7.8-mm ×10-cm column that contains packing L34.The column temperature is maintained at a constant temperature of about 60,controlled to within ±2,and the flow rate is about 0.5mLper minute.Chromatograph theStandard preparation,and record the peak responses as directed forProcedure:the relative retention times are about 0.38for maltotriitol,0.48for maltitol,and 1.0for sorbitol;the tailing factor for maltitol and sorbitol is not more than 1.2;and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10µL)of theAssay preparation and theStandard preparation into the chromatograph,record the chromatograms,and measure the responses for the major peaks.Separately calculate the percentages,on the anhydrous basis,of D-maltitol and D-sorbitol in the portion of Maltitol Solution taken by the formula:
[10,000(CS/CU)(rU/rS)]/(100–W),
in whichCSis the concentration,in mg per g,of the appropriate USP Reference Standard in theStandard preparation;CUis the concentration,in mg per g,of Maltitol Solution in the Assay preparation;rUand rSare the peak responses of the corresponding analyte obtained from theAssay preparation and theStandard preparation,respectively;andWis the percentage obtained in the test for Water.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3032
Pharmacopeial Forum:Volume No.30(3)Page 984
Phone Number:1-301-816-8262