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Prepared at the 44th JECFA (1995), published in FNP 52 Add 3 (1995) superseding specifications prepared at the 41st JECFA (1993), published in FNP 52 Add 2 (1993) |
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SYNONYMS |
Hydrogenated high maltose-content glucose syrup, hydrogenated glucose syrup, dried maltitol syrup, maltitol syrup powder, INS No. 965 |
DEFINITION |
A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides; manufactured by the catalytic hydrogenation of high maltose-content glucose syrup; typically supplied as a syrup; may also be dried and supplied as a solid product |
Assay |
The following ranges apply on the anhydrous basis: Maltitol: not less than 50% Sorbitol: not more than 8% Maltotriitol: not more than 25% Hydrogenated polysaccharides containing more than three glucose or glucitol units: not more than 30% |
DESCRIPTION |
Colourless and odourless, clear viscous liquids or white crystalline masses |
FUNCTIONAL USES |
Sweetener, humectant, stabilizer |
CHARACTERISTICS | |
IDENTIFICATION | |
Solubility |
Very soluble in water, slightly soluble in ethanol |
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 waterTest solution:Dissolve 50 mg of the sample in 20 ml of water |
PURITY | |
Water |
Not more than 31% (Karl Fischer Method) |
Sulfated ash |
Not more than 0.1% Test 3 g of the 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 0.3% Proceed as directed under Reducing Substances (as glucose), Method II. The weight of cuprous oxide shall not exceed 50 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 |
Maltitol, sorbitol, maltotriitol and higher molecular weight hydrogenated polysaccharides are determined using High performance liquid chromatography.
Apparatus- High performance liquid chromatograph (HPLC) - Detection: Differential refractometer maintained at constant temperature - Integrator recorder - 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 1.2 µm)
Chromatographic conditionsColumn temperature: 85±0.5o Eluent flow rate: 0.5 ml/min
Standard preparation:Dissolve an accurately weighed quantity of standard reference maltitol (available from US Pharmacopial Convention, Inc. 12601 Twinbrook Parway, Rockville, MD 20852, USA) in water to obtain a solution having known concentration of about 10.0 mg of maltitol per ml.
Assay 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 each maltitol peak. Calculate separately the quantities, in mg, of maltitol and other hydrogenated saccharides in the portion of syrup taken by the following formula:
where C = the concentration, in mg per ml, of maltitol in the standard preparation RU = the peak response of the sample preparation RS = the peak response of the standard preparation.
Note: the elution pattern usually includes a broad band of closely spaced peaks starting from the higher molecular weight hydrogenated polysaccharides, followed by 3 individual peaks representing in the order of elution: maltotriitol, maltitol and sorbitol. The principal peak is maltitol which elutes at about twice the retention time of the higher molecular weight hydrogenated polysaccharides. |