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Sorbitol Powder and Sorbitol Solution 70% Syrup USP FCC Food Grade Supplier Exporter Manufacturers' Representative

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Sorbitol Powder and Sorbitol Solution 70% Syrup
CAS Number: 50-70-4

Molecular Formula: C6H14O6
Molecular Weight: 182.17

Sorbitol Powder Suppliers Sorbitol 70% Solution Suppliers
Sorbitol Powder and Sorbitol Solution 70% Syrup

Specifications of Sorbitol Solution USP Grade:

DEFINITION
Sorbitol Solution is an aqueous solution containing NLT 64.0% of d-sorbitol (C6H14O6 ). The amounts of total sugars, other polyhydric alcohols, and any hexitol anhydrides, if detected, are not included in the requirements or in the calculated amount under General Notices, 5.60.10. Other Impurities in USP and NF Articles.

IDENTIFICATION
A. Procedure
Sample solution: Dissolve 1.4 g of Sorbitol Solution in 75 mL of water.
Analysis: Transfer 3 mL of the Sample solution to a 15-cm test tube. Add 3 mL of freshly prepared catechol solution (1 in 10), and mix. Add 6 mL of sulfuric acid, mix again, and gently heat the tube in a flame for 30 s.
Acceptance criteria: A deep pink or wine-red color appears.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Limit of Diethylene Glycol and Ethylene Glycol: To pass the test.
Acceptance criteria:
Diethylene glycol: The peak area of diethylene glycol in the Sample solution is NMT the peak area of diethylene glycol in the Standard solution, corresponding to NMT 0.10% of diethylene glycol in Sorbitol Solution.
Ethylene glycol: The peak area of ethylene glycol in the Sample solution is NMT the peak area of ethylene glycol in the Standard solution, corresponding to NMT 0.10% of ethylene glycol in Sorbitol Solution.

ASSAY
To pass the test.
Acceptance criteria: NLT 64.0%

Residue on Ignition: NMT 0.1%, calculated on the anhydrous basis, determined on a 2-g portion
Limit of Nickel:
To pass the test.
Acceptance criteria: NMT 1 ppm, calculated on the anhydrous basis.
Procedure: Reducing Sugars:
Sample: Equivalent to 3.3 g of sorbitol on the anhydrous basis from Sorbitol Solution.
Analysis: To the Sample, add 3 mL of water, 20.0 mL of cupric citrate TS, and a few glass beads. Heat so that boiling begins after 4 min, and maintain boiling for 3 min. Cool rapidly, and add 40 mL of diluted acetic acid, 60 mL of water, and 20.0 mL of 0.05 N iodine VS. With continuous shaking, add 25 mL of a mixture of 6 mL of hydrochloric acid and 94 mL of water. When the precipitate has dissolved, titrate the excess of iodine with 0.05 N sodium thiosulfate using 2 mL of starch, added toward the end of the titration, as an indicator.
Acceptance criteria: NLT 12.8 mL of 0.05 N sodium thiosulfate VS is required, corresponding to NMT 0.3% of reducing sugars, on the anhydrous basis, as glucose. [Note— The amount determined in this test is not included in the calculated amount under General Notices, 5.60.10. Other Impurities in USP and NF Articles .]
pH: 5.0–7.5, in a 14% (w/w) solution of Sorbitol Solution in carbon dioxide-free water.
Water Determination: 28.5%–31.5%.


Specifications of Sorbitol FCC Food Grade:
D-Sorbitol; D-Glucitol; D-Sorbite; 1,2,3,4,5,6-Hexanehexol
C6H14O6 Formula weight 182.17
INS: 420 CAS 50-70-4

DESCRIPTION
Sorbitol occurs as a white powder, as granules, or as crystalline masses. It is very soluble in water; slightly soluble in ethanol, in methanol, and in acetic acid; and insoluble in ether. It is hygroscopic.
Function: Humectant; texturizing agent; nutritive sweetener.

REQUIREMENTS
Identification:
A. Dissolve 1 g of sample in 75 mL of water. Transfer 3 mL of this solution into a 15-cm test tube, add 3 mL of a freshly prepared 1:10 catechol solution, and mix. Add 6 mL of sulfuric acid, mix again, then gently heat the tube in a flame for about 30 s. A deep pink or wine-red color appears.
B. The retention time of the major peak in the chromatogram of the Assay Solution corresponds to that in the chromatogram of the Standard Solution obtained in the Assay.
Assay: Not less than 91.0% and not more than 100.5% of D-Sorbitol (C6H14O6), calculated on the anhydrous basis.
Lead: Not more than 2 mg/kg.
Nickel: Not more than 1 mg/kg.
pH of a 10% (w/w) Solution: Between 3.5 and 7.0.
Reducing Sugars: Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.
Water: Not more than 1.5%.

We also supply Sorbitol Powder and Sorbitol Solution 70% Syrup Crystallising, Non-crystallising and Partially Dehydrated Liquid Sorbitol of BP Ph Eur grade.

Please visit SDS Safety Data Sheet of Sorbitol Powder Solution 70% Syrup 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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