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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) |
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SYNONYMS |
D-Glucitol syrup, INS No. 420 |
DEFINITION |
Formed by hydrogenation of glucose syrup; composed of D-sorbitol, D-mannitol and other hydrogenated saccharides
The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallizing) or mannitol; minor quantities of hydrogenated di-, tri- and tetrasaccharides may be present |
Assay |
Not less than 99.0% hydrogenated saccharides and not less than 50.0% of D-sorbitol on the anhydrous basis |
DESCRIPTION |
Clear colourless aqueous solution |
FUNCTIONAL USES |
Sweetener, humectant, sequestrant, texturizer, bulking agent |
CHARACTERISTICS | |
IDENTIFICATION | |
Solubility |
Soluble in water, glycerol and propan-1,2-diol |
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 sorbitol (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 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 a solution of 2 g of the sample in 25 ml water as directed in the Limit Test (Method I) |
METHOD OF ASSAY |
Total hydrogenated saccharides (%):
Determine the sorbitol content of the sample using liquid chromatography.
ApparatusLiquid 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 conditionsColumn temperature: 85±0.5o Eluent flow rate: 0.5 ml/min
Standard preparationDissolve an accurately weighed quantity of sorbitol in water to obtain a solution having known concentration of about 10.0 mg of sorbitol per ml.
Sample preparationTransfer about 1 g of the sample accurately weighed to a 50 ml volumetric flask, dilute with water to volume and mix.
ProcedureSeparately 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 polyol peak. Calculate separately the quantity, in mg, of sorbitol in the portion of sample taken by the following formula:
where C = concentration, in mg per ml, of sorbitol in the standard preparation RU = the peak response of the sample preparation RS = the peak response of the standard preparation. |