Noncrystallizing Sorbitol Solution
» Noncrystallizing Sorbitol Solution is an aqueous solution containing not less than 45.0 percent 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. No storage requirements specified.
A: Dissolve 1.4 g of Noncrystallizing Sorbitol Solution in 75 mL of water. Transfer 3 mL of this solution to a 15-cm test tube, add 3 mL of freshly prepared catechol solution (1 in 10), mix, add 6 mL of sulfuric acid, mix again, and gently heat the tube in a flame for about 30 seconds: a deep pink or wine-red color appears.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 The total aerobic microbial count using the Plate Method is not more than 1000 cfu per mL, and the total combined molds and yeasts count is not more than 100 cfu per mL.
pH 791: between 5.0 and 7.5, in a 14% (w/w) solution of Noncrystallizing Sorbitol Solution in carbon dioxide-free water.
Water, Method I 921: between 28.5% and 31.5%.
Residue on ignition 281: 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 3.3 g on the anhydrous basis, add 3 mL of water, 20.0 mL of cupric citrate TS, and a few glass beads. Heat so that boiling begins after 4 minutes, and maintain boiling for 3 minutes. Cool rapidly, and add 40 mL of diluted acetic acid, 60 mL of water, and 20.0 mL of 0.05 N iodine VS. With continuous shaking, add 25 mL of a mixture of 6 mL of hydrochloric acid and 94 mL of water. When the precipitate has dissolved, titrate the excess of iodine with 0.05 N sodium thiosulfate VS using 2 mL of starch TS, added towards the end of the titration, as an indicator. Not less than 12.8 mL of 0.05 N sodium thiosulfate VS is 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 under Other Impurities.
Limit of nickel Proceed as directed in the test for Limit of nickel under Sorbitol Solution. Not more than 1 µg per g, calculated on the anhydrous basis, is found.
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Sorbitol.
Assay preparation Accurately weigh about 0.20 g of Noncrystallizing Sorbitol Solution, and dissolve in and dilute with water to about 20 g. Accurately record the final solution weight, and mix thoroughly.
Procedure Proceed as directed in the Assay under Sorbitol. Calculate the percentage of d-sorbitol (C6H14O6) in the portion of Noncrystallizing Sorbitol Solution taken by the formula:
100(CS / CU)(rU / rS)in which CS is the concentration, in mg per g, of USP Sorbitol RS in the Standard preparation; CU is the concentration, in mg per g, of Noncrystallizing Sorbitol Solution in the Assay preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 1353Pharmacopeial Forum: Volume No. 30(3) Page 995
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.