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MALTITOL-麦芽糖醇

2013-09-03 3页 pdf 136KB 28阅读

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MALTITOL-麦芽糖醇 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). Metals and arsenic specifications were revised by JECFA in 2001*. An...
MALTITOL-麦芽糖醇
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). Metals and arsenic specifications were revised by JECFA in 2001*. An ADI 'not specified' was established at the 41st JECFA (1993) 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 (Vol. 4) Very soluble in water, slightly soluble in ethanol Melting range (Vol. 4) 148 - 151o Thin layer chromatography (Vol. 4) 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 Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD 20852, USA) in 20 ml water Test solution Dissolve 50 mg of the sample in 20 ml of water PURITY Water (Vol. 4) Not more than 1.0% (Karl Fischer Method) Specific rotation (Vol. 4) [alpha] 20, D: Between +105.5 and +108.5o(5% w/v solution) Sulfated ash (Vol. 4) Not more than 0.1% Test 2 g of sample (Method I) Chlorides (Vol. 4) 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 (Vol. 4) 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 (Vol. 4) Not more than 2 mg/kg Proceed as directed under Nickel in Polyols Reducing sugars (Vol. 4) 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 (Vol. 4) Not more than 1 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.” METHOD OF ASSAY Determine the maltitol content of the sample using liquid chromatography (see Volume 4) 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 ± 0.5o ; 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 RU = the peak response of the sample preparation RS = the peak response of the standard preparation *The specification for Maltitol was not revised in 2001. This revision will be adopted by the 67th JECFA (2006). MALTITOL SYNONYMS DEFINITION Chemical names C.A.S. number Chemical formula Structural formula Formula weight Assay DESCRIPTION FUNCTIONAL USES CHARACTERISTICS IDENTIFICATION Standard solution Test solution PURITY Nickel (Vol. 4) METHOD OF ASSAY Apparatus Standard preparation Sample preparation Procedure
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