Packaging and storage—
Preserve in well-closed containers. No storage requirements specified.
Identification—
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 limits 
61
—
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.
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.
Assay—
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 (C
6H
14O
6) 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—
Staff Liaison :
Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29–NF24 Page 3434
Pharmacopeial Forum : Volume No. 30(3) Page 995
Phone Number : 1-301-816-8262
