Compressible Sugar
»Compressible Sugar,previously dried at 105for 4hours,contains not less than 95.0percent and not more than 98.0percent of sucrose (C12H22O11).It may contain starch,malto-dextrin,or invert sugar,and may contain a suitable lubricant.
Packaging and storage— Preserve in well-closed containers.
Identification— The specific rotation of the uninverted solution obtained in the Assayis not less than 62.6,and the acid-inverted solution obtained in the Assayis levorotatory.
Microbial limits á61ñ— It meets the requirements of the tests for the absence of Salmonellaspecies and Escherichia coli.
Loss on drying á731ñ— Dry it at 105for 4hours:it loses between 0.25%and 1.0%of its weight.
Residue on ignition á281ñ: not more than 0.1%.
Chloride,Sulfate,Calcium,and Heavy metals— Transfer about 20g,accurately weighed,to a 100-mLvolumetric flask,add 80mLof water,shake to dissolve the sucrose,then add water to volume,and mix.Separate the solubilized sucrose from any insoluble matter by filtration until the filtrate is sparkling clear,and use the freshly prepared,clear filtrate for the following tests.
Chloride á221ñ— A10-mLportion shows no more chloride than corresponds to 0.40mLof 0.020Nhydrochloric acid (0.014%).
Sulfate á221ñ— A25-mLportion shows no more sulfate than corresponds to 0.50mLof 0.020Nsulfuric acid (0.010%).
Calcium á191ñ— To a 5-mLportion add 1mLof ammonium oxalate TS:the solution remains clear for not less than 1minute.
Heavy metals á231ñ— To a 20-mLportion add 4mLof water and 1mLof 0.1Nhydrochloric acid:the limit is 5ppm.
Assay— Transfer 26.0g of Compressible Sugar,previously dried and accurately weighed,to a 100-mLvolumetric flask,add about 0.3mLof a saturated aqueous solution of lead acetate,shake with about 90mLof water,dilute with water to volume,and mix.Distribute evenly on the surface of a sheet of medium-fast filter paper about 8g of chromatographic siliceous earth suitable for column partition chromatography (see under Reagentsin the section Reagents,Indicators,and Solutions),and filter the solution,with the aid of vacuum,discarding the first 20mLof the filtrate.Pipet 25mLof the subsequent clear filtrate into each of two 50-mLvolumetric flasks.Slowly add 6mLof dilute hydrochloric acid (1in 2)to one flask while rotating it,dilute with water nearly to volume,and mix.Place the flask in a water bath maintained at a temperature of 60,continuously shake the flask in the bath for about 3minutes,and allow the flask to remain in the bath for a total of 10minutes.Immediately cool to 20by plunging the flask into a cold bath,dilute with water to volume at 20,and mix.Cool the contents of the second flask to 20,dilute with water to volume at 20,and mix.Maintain both flasks at a temperature of 20for 30minutes.Determine the specific rotation of each solution at 20as directed under Optical Rotation á781ñ.Calculate the percentage of C12H22O11taken by the formula:
100(ao-ai)/88.3,
in which aoand aiare the specific rotations of the uninverted and acid-inverted solutions,respectively.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3095
Phone Number:1-301-816-8143