Maltitol Solution
» Maltitol Solution is a water solution containing, on the anhydrous basis, not less than 50.0 percent of d-maltitol (C12H24O11) (w/w), and not more than 8.0 percent 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. No storage requirements specified.
A: Dissolve 1.4 g of Maltitol 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), and mix. Add 6 mL of sulfuric acid, mix, 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 Maltitol Solution in carbon dioxide-free water.
Water, Method I 921: not more than 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 Maltitol 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— Use degassed water.
Standard preparation— Dissolve accurately weighed quantities of USP Maltitol RS and USP Sorbitol RS in water to obtain a solution having known concentrations of about 10 mg per g and 1.6 mg per g, respectively.
Assay preparation— Accurately weigh about 0.4 g of Maltitol Solution, and dissolve in and dilute with water to about 20 g. Accurately record the final solution weight, and mix thoroughly.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a refractive index detector that is maintained at a constant temperature of about 35 and 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 0.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are about 0.38 for maltotriitol, 0.48 for maltitol, and 1.0 for 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 10 µL) of the Assay preparation and the Standard 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 which CS is the concentration, in mg per g, of the appropriate USP Reference Standard in the Standard preparation; CU is the concentration, in mg per g, of Maltitol Solution in the Assay preparation; rU and rS are the peak responses of the corresponding analyte obtained from the Assay preparation and the Standard preparation, respectively; and W is the percentage obtained in the test for Water.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, B.A.
(EM105) Excipient Monographs 1
Reference Standards Lili Wang, Technical Services Scientist
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1275
Pharmacopeial Forum: Volume No. 30(3) Page 984
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.