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Polydextrose
CAS Number: 68424-04-4
Molecular Formula: (C6H12O6)x
Molecular Weight: Varies
Polydextrose
Polydextrose is a synthetic polymer of glucose. It is a food ingredient classified as soluble fiber by the US FDA as well as Health Canada. It is frequently used to increase the dietary fiber content of food, to replace sugar, and to reduce calories and fat content. Its E number is E1200. Polydextrose is frequently used as an ingredient in low-carb, sugar-free, and diabetic cooking recipes. It is also used as a humectant, stabilizer, and thickening agent. As a pharmaceutical excipient, polydextrose is mainly used in the production of solid dosage forms.
Specifications of Polydextrose USP NF Grade:
CAS 68424-04-4
DEFINITION
Polydextrose is a randomly branched polymer prepared by melting and subsequent condensation of the ingredients, which consist of approximately 90 parts dextrose, 10 parts sorbitol, and up to 1-part citric acid or 0.1-part phosphoric acid. The 1,6-glycosidic linkage predominates in the polymer, but other linkages are present. It contains NLT 90.0% of dextrose polymer units, calculated on the anhydrous and ash-free basis. It contains small quantities of free dextrose, sorbitol, and 1,6-anhydro-d-glucose (levoglucosan), with traces of citric acid or phosphoric acid.
IDENTIFICATION
A. To 1 drop of a solution (1 in 10), add 4 drops of 5% phenol solution, then rapidly add 15 drops of sulfuric acid TS: a deep yellow to orange color is produced.
B. With vigorous swirling, add 1 mL of acetone to 1 mL of a solution (1 in 10): the solution remains clear.
C. With vigorous swirling, add 2 mL of acetone to the solution obtained in Identification test B: a heavy, milky turbidity develops immediately.
D. To 1 mL of a solution (1 in 50), add 4 mL of alkaline cupric citrate TS. Boil vigorously for 2–4 min. Remove from heat and allow the precipitate (if any) to settle: the supernatant is blue or blue-green.
Residue on Ignition: NMT 0.3%
Limit of Lead: To pass the test.
Procedure 1: Limit of 5-Hydroxymethylfurfural and Related Compounds: To pass the test.
Procedure 2: Limit of Monomers: To pass the test.
Molecular Weight Limit: To pass the test.
Acceptance criteria: No measurable peak above a molecular weight of 22,000 is found.
pH: 2.5–5.0, in a solution (1 in 10)
Water Determination: NMT 4.0%. Use a mixture of Hydranal solvent and Hydranal formamide dry (2:1) as a solvent. Perform the titration at 50° in a jacketed beaker.
Polydextrose FCC Food Grade Specifications:
INS: 1200 CAS 68424-04-4
DESCRIPTION
Polydextrose occurs as an off white to light tan solid. It is a randomly bonded polymer prepared by the condensation of a melt that consists of approximately 90% D-glucose, 10% sorbitol, and 1% citric acid or 0.1% phosphoric acid on a weight basis. The 1,6-glycosidic linkage predominates in the polymer, but other possible bonds are present. The product contains small quantities of free glucose, sorbitol, and Danhydroglucoses (levoglucosan), with traces of citric acid or phosphoric acid. It may be partially reduced by transition metal catalytic hydrogenation in an aqueous solution. It may be neutralized with any food-grade base and decolorized and deionized for further purification. It is very soluble in water.
Function Bulking agent; humectant; texturizer.
REQUIREMENTS
Identification:
A. Add 4 drops of 5% aqueous phenol solution to 1 drop of a 1:10 aqueous solution, then rapidly add 15 drops of sulfuric acid. A deep yellow to orange color appears.
B. While vigorously swirling (vortex mixer), add 1.0 mL of acetone to 1.0 mL of a 1:10 aqueous solution. The solution remains clear. Retain this solution for Identification Test C.
C. While vigorously swirling, add 2.0 mL of acetone to the solution from Identification Test B. A heavy, milky turbidity develops immediately.
D. Add 4 mL of alkaline cupric citrate TS to 1 mL of a 1:50 aqueous solution. Boil vigorously for 2 to 4 min. Remove from heat, and allow the precipitate (if any) to settle. The supernatant liquid is blue or blue-green.
Assay: Not less than 90.0% polymer, calculated on the anhydrous, ash-free basis.
5-Hydroxymethylfurfural and Related Compounds: Not more than 0.1%, calculated on the anhydrous, ash-free basis.
Lead: Not more than 0.5 mg/kg.
Molecular Weight Limit: Passes test.
Monomers: D-Anhydroglucoses: Not more than 4.0%, calculated on the anhydrous, ash-free basis; Glucose and Sorbitol: Not more than 6.0%, calculated on the anhydrous, ash-free basis.
Nickel: Not more than 2 mg/kg for hydrogenated Polydextrose.
pH of a 10% Solution: Untreated Polydextrose: Between 2.5 and 7.0; Neutralized or Decolorized Polydextrose: Between 5.0 and 6.0.
Residue on Ignition: Untreated Polydextrose: Not more than 0.3%; Neutralized or Decolorized Polydextrose: Not more than 2.0%.
Water Not more than 4.0%.
Please visit SDS Safety Data Sheet of Polydextrose Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
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