Maltitol
344.31d-Glucopyranosyl-d-glucitol
[585-88-6].» Maltitol contains not less than 92.0 percent and not more than 100.5 percent of d-maltitol, calculated on the anhydrous basis. The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements or in the calculated amount under Other Impurities in General Notices and Requirements.
Packaging and storage—
Preserve in well-closed containers. No storage requirements specified.
Identification—
A:
Dissolve 1 g of Maltitol 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 again, then 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 does not exceed 1000 cfu per g and the total combined molds and yeasts count does not exceed 100 cfu per g.
61 and Tests for specified microorganisms 62—
The total aerobic microbial count using the Plate Method does not exceed 1000 cfu per g and the total combined molds and yeasts count does not exceed 100 cfu per g.
Conductivity—
Dissolve 20.0 g of Maltitol in water, and dilute with the same solvent to 100.0 mL. Using an appropriate conductivity meter, choose a conductivity cell that is appropriate for the properties and conductivity of the solution to be examined. Use a certified reference material,* for example a solution of potassium chloride, that is appropriate for the measurement. The conductivity value of the certified reference material should be near the expected conductivity value of the solution to be examined. After calibrating the apparatus with a certified reference material solution, rinse the conductivity cell several times with water and at least twice with the aqueous solution to be examined. Measure the conductivity of the solution at a temperature of 20
, while gently stirring with a magnetic stirrer: the conductivity is not more than 20 µS per cm.
, while gently stirring with a magnetic stirrer: the conductivity is not more than 20 µS per cm.
Water, Method I 921:
not more than 1.0%.
921:
not more than 1.0%.
Reducing sugars—
Dissolve 3.3 g of Maltitol in 3 mL of water with the aid of gentle heat. Cool, and add 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, as glucose. The amount determined in this test is not included in the calculated amount under Other Impurities.
Limit of nickel—
Not more than 1 µg per g, calculated on the anhydrous basis, is found. Proceed as directed in the test for Limit of nickel under Sorbitol.
Assay—
Mobile phase—
Use degassed water.
Standard preparation—
Dissolve accurately weighed quantities of USP Maltitol RS and sorbitol in water, to obtain a solution having known concentrations of about 10 mg per g and 1.6 mg per g, respectively.
Resolution solution—
Dissolve accurately weighed quantities of USP Maltitol RS and sorbitol in water to obtain a solution having known concentrations of about 4.8 mg of each per g.
Assay preparation—
Dissolve about 0.20 g of Maltitol, accurately weighed, in water, and dilute with water to about 20 g. Accurately record the final solution weight, and mix thoroughly.
Chromatographic system (see Chromatography 621)—
The liquid chromatographic system is equipped with a refractive index detector 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 about 60, controlled to within ±2, and the flow rate is about 0.5 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.48 for maltitol, and 1.0 for sorbitol; the resolution, R, between maltitol and sorbitol is not less than 2.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.
621)—
The liquid chromatographic system is equipped with a refractive index detector 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 about 60, controlled to within ±2, and the flow rate is about 0.5 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.48 for maltitol, and 1.0 for sorbitol; the resolution, R, between maltitol and sorbitol is not less than 2.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: 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. Calculate the percentage, on the anhydrous basis, of C12H24O11 in the portion of Maltitol taken by the formula:
[10,000(CS / CU)(rU / rS)]/(100 – W)
in which CS is the concentration, in mg per g, of USP Maltitol RS in the Standard preparation; CU is the concentration, in mg per g, of Maltitol in the Assay preparation; rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively; and W is the percentage obtained in the test for Water.
*
Commercially available conductivity calibration solutions for conductivity meter standardization, standardized by methods traceable to the National Institute of Standards and Technology (NIST), may be used. Solutions prepared according to instructions given in ASTM Standard D1125 may be used provided the conductivity of the resultant solution is the same as that of the solution prepared from the NIST-certified material.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Robert H. Lafaver, B.A.
Scientist 1-301-816-8335 |
(EM105) Excipient Monographs 1 |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 1274
Pharmacopeial Forum: Volume No. 31(4) Page 1143
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.