MALTITOL


	Prepared at the 46th JECFA (1996), published in FNP 52 Add 4 (1996) superseding specifications prepared at the 33rd JECFA (1988), published in FNP 38 (1988) and in FNP 52 (1992)
SYNONYMS	D-Maltitol, hydrogenated maltose, INS No. 965
DEFINITION
Chemical names	alpha-D-Glucopyranosyl-1,4-D-glucitol
C.A.S. number	585-88-6
Chemical formula	C₁₂H₂₄O₁₁
Structural formula
Formula weight	344.31
Assay	Not less than 98.0%
DESCRIPTION	White crystalline powder
FUNCTIONAL USES	Sweetener, humectant, stabilizer, bulking agent
CHARACTERISTICS
IDENTIFICATION
Solubility	Very soluble in water, slightly soluble in ethanol
Melting range	148 - 151^o
Thin layer chromatography	Passes test Proceed as directed under Thin Layer Chromatography of Polyols Use the following: Standard solution: Dissolve 50 mg of reference standard maltitol (available from US Pharmacopial Convention, Inc. 12601 Twinbrook Parway, Rockville, MD 20852, USA) in 20 ml water Test solution: Dissolve 50 mg of the sample in 20 ml of water
PURITY
Water	Not more than 1.0% (Karl Fischer Method)
Specific rotation	[alpha] 20, D: Between +105.5 and +108.5^o(5% w/v solution)
Sulfated ash	Not more than 0.1% Test 2 g of sample (Method I)
Chlorides	Not more than 50 mg/kg Test 10 g of sample by the Limit Test using 1.5 ml of 0.01N hydrochloric acid in the control
Sulfates	Not more than 100 mg/kg Test 10 g of sample by the Limit Test using 2.0 ml of 0.01N sulfuric acid in the control
Nickel	Not more than 2 mg/kg Proceed as directed under Nickel in Polyols
Reducing sugars	Not more than 0.1% Proceed as directed under Reducing Substances (as glucose), Method II. The weight of cuprous oxide shall not exceed 20 mg
Lead	Not more than 1 mg/kg Prepare a sample solution as directed in the Limit Test for organic compounds and determine the lead content by atomic absorption spectrometry
Heavy metals	Not more than 10 mg/kg Test 2 g of the sample as directed in the Limit Test (Method II)
METHOD OF ASSAY	Determine the maltitol content of the sample using liquid chromatography Apparatus Liquid chromatograph (HPLC) Detection: Differential refractometer maintained at constant temperature Integrator recorder Column: AMINEX HPX 87 C (or equivalent resin in calcium form), length 30 cm, internal diameter 9 mm Eluent: Double distilled degassed water (filtered through Millipore membrane filter 0.45 µm) Chromatographic conditions Column temperature: 85 ± 0.5^o Eluent flow rate: 0.5 ml/min Standard preparation: Dissolve an accurately weighed quantity of standard reference maltitol 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. Procedure: Separately inject equal volumes (about 20 µl) of the sample preparation and the standard preparation into the chromatograph. Record the chromatograms and measure the responses of the maltitol peak. Calculate the quantity, in mg, of maltitol in the portion of sample taken by the following formula: where C = the concentration, in mg per ml, of maltitol in the standard preparation R_U = the peak response of the sample preparation R_S = the peak response of the standard preparation

Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

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