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Maltitol syrup

Prepared at the 49th JECFA (1997)
superseding specifications prepared at the 46th JECFA (1996),
published in FNP 5 2 Addendum 4 (1996)


Hydrogenated high maltose-content glucose syrup, hydrogenated glucose syrup, dried maltitol syrup, maltitol syrup powder INS No. 965


A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo-and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup. The article of commerce is typically supplied as a syrup. It may also be dried and supplied as a solid product


Not less than 99.0% of total hydrogenated saccharides on the anhydrous basis and not less than 50.0% of maltitol on the anhydrous basis


Colourless and odourless, clear viscous liquids or white crystalline masses


Sweetener, humectant, texturizer, stabilizer, bulking agent




Very soluble in water, slightly soluble in ethanol

Thin layer chromatography

Passes test See description under TESTS



Not more than 31% (Karl Fischer)

Sulfated ash

Not more than 0.1 %
Test 3 g of sample as directed under the test for Ash (Sulfated ash) Method I


Not more than 50 mg/kg
Test 10 g of the sample by the Limit Test using 1.5 ml of 0.01 N hydrochloric acid in the standard


Not more than 100 mg/kg Test 10 g of the sample by the Limit Test using 2.0 ml of 0.01 N sulfuric acid in the standard


Not more than 2 mg/kg
See description under TESTS


Not more than 1 mg/kg
Prepare a sample solution as directed for organic compounds in the Limit Test and determine the lead content by atomic absorption spectrometry

Reducing sugars

Not more than 0.3%
Proceed as described in the method for Reducing Substances (as glucose), Method II. The weight of cuprous oxide shall not exceed 50 mg



Thin layer chromatography

Examine by thin layer chromatography using silica gel as the coating substance

Standard solution:
Dissolve 50 mg of reference standard maltitol (available from US Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, USA) in 20 ml water

Test solution:
Dissolve 50 mg of sample in 20 ml of water

4-Aminobenzoic acid reagent:
Prepare a solution by dissolving 1 g of 4-aminobenzoic acid in a solvent mixture composed of 18 ml acetic acid, 20 ml water and 1 ml phosphoric acid. Prepare this reagent immediately before use.

Sodium periodate reagent:
A solution of 0.2% w/v sodium periodate in water

Apply 2 m l of each of the standard and test solution to the bottom of the TLC plate. Develop the chromatogram over a path of 17 cm using as the mobile phase a mixture of 70 volumes of propanol, 20 volumes of ethyl acetate and 10 volumes of water. Allow the plate to dry in air and spray with a mixture of 2 volumes of 4-aminobenzoic acid reagent with 3 volumes of acetone. Heat at 100° for 15 min. Spray with the sodium periodate reagent. Heat at 100° for 15 min. The principal spot in the chromatogram obtained from the test solution corresponds in position, colour and size to the principal spot obtained from the standard solution.



Test solution:
Dissolve 20.0 g of the sample in a mixture of equal volumes of dilute acetic acid TS and water and dilute to 100 ml with the same mixture of solvents. Add 2.0 ml of a 1% w/v solution of ammonium pyrrolidinedithiocarbamate and 10 ml of methyl isobutyl ketone. Mix and allow the layers to separate and use the methyl isobutyl ketone layer for analysis.

Standard solutions:
Prepare three standard solutions in the same manner as the test solution but adding 0.5 ml, 1.0 ml, and 1.5 ml, respectively, of a standard nickel solution containing 10 mg/l Ni, in addition to the 20.0 g of the sample.

Set the instrument to zero using methyl isobutyl ketone prepared as described for the preparation of the test solution but omitting the substance to be examined. Use a nickel hollow-cathode lamp as source of radiation and an air-acetylene flame. The analysis wavelength for all solutions is 232.0 nm.


Total hydrogenated saccharides (%):

Maltitol is determined by High Performance Liquid Chromatography (HPLC) using the following conditions:

- Detection: Differential refractometer maintained at constant temperature
- Integrator recorder -Liquid chromatograph (HPLC)
- Column: AMINEX HPX 87 C (resin in calcium form), length 30 cm, internal diameter 9 mm
- Eluent: Double distilled degassed water (filtered through Millipore membrane filter 0.45 m m)

Chromatographic conditions:
Column temperature: 85 ± 0.5°
Eluent flow rate: 0.5 ml/min

Standard preparation:
Dissolve an accurately weighed quantity of standard reference maltitol (available from US Pharmacopeial Convention Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, USA) in water to obtain a solution having known concentration of about 10.0 mg of maltitol per ml.

Sample preparation:
Transfer about 1 g of the sample accurately weighed to a 50-ml volumetric flask, dilute with water to volume and mix.

Separately inject equal volumes (about 20 m l) of the sample preparation and the standard preparation into the chromatograph. Record the chromatograms and measure the responses of each maltitol peak. Calculate the quantity, in mg, of maltitol in the syrup by the following formula:

in which C is the concentration, in mg per ml, of maltitol in the standard preparation; RU is the peak response of maltitol from the sample preparation and RS is the peak response of the standard preparation.

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