American Molecules - Ammol.org USA

Maltitol & Maltitol Solution Syrup USP NF FCC Food Grade Supplier Exporter Manufacturers' Representative

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Maltitol & Maltitol Solution Syrup
CAS Number: 585-88-6

Molecular Formula: C12H24O11
Molecular Weight: 344.31

Maltitol Suppliers Maltitol Solution Syrup Suppliers
Maltitol & Maltitol Solution Syrup

Maltitol & Maltitol Solution Syrup has an E number of E965.

Specifications of Maltitol USP NF Grade:
C12H24O11 --- 344.31
d-Glucopyranosyl-d-glucitol --- CAS 585-88-6

DEFINITION
Maltitol contains NLT 92.0% and NMT 100.5% of d-maltitol (C12H24O11 ), calculated on the anhydrous basis. The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements or in the calculated amount in General Notices and Requirements, 5.60.10 Other Impurities in USP and NF Articles.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

ASSAY
To pass the test by Chromatography
Acceptance criteria: 92.0%–100.5% on the anhydrous basis
Limit of Nickel:
To pass the test
Acceptance criteria: NMT 1 micro-g/g
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, as glucose.
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate Method does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.
Conductivity:
To pass the test
Acceptance criteria: NMT 20 µS/cm
Water Determination: NMT 1.0%


Specifications of Maltitol Solution USP NF Grade:

DEFINITION
Maltitol Solution is a water solution containing, on the anhydrous basis, NLT 50.0% of d-maltitol (C12H24O11 ) (w/w) and NMT 8.0% of d-sorbitol (C6H14O6 ) (w/w). The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements nor in the calculated amount under Other Impurities.

IDENTIFICATION
A. Procedure
Sample: 1.4 g of Maltitol Solution
Analysis: Dissolve the Sample in 75 mL of water. Transfer 3 mL of this solution to a 15-cm test tube, add 3 mL of freshly prepared catechol (1 in 10), and mix. Add 6 mL of sulfuric acid, and mix. Gently heat the tube in a flame for about 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 by Chromatography
Acceptance criteria
Diethylene glycol: The peak area ratio of diethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of diethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of diethylene glycol in Maltitol Solution.
Ethylene glycol:  The peak area ratio of ethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of ethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of ethylene glycol in Maltitol Solution.

ASSAY
To pass the test by Chromatography
Acceptance criteria: NLT 50.0% of d-maltitol (w/w) and NMT 8.0% of d-sorbitol (w/w), on the anhydrous basis

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
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, on the anhydrous basis, as glucose.
Microbial Enumeration Tests and Tests for Specific Microorganisms: The total aerobic microbial count using the Plate Method is NMT 1000 cfu/mL, and the total combined molds and yeasts count is NMT 100 cfu/mL.
pH: 5.0–7.5, in a 14% (w/w) solution of Maltitol Solution in carbon dioxide-free water
Water Determination: NMT 31.5%


Specifications of Maltitol FCC Food Grade:
D-Maltitol; Hydrogenated Maltose; _-D-Glucopyranosyl-1,4-D-glucitol
C12H24O11 Formula weight 344.31
INS: 965 CAS 585-88-6

DESCRIPTION
Maltitol occurs as a white, crystalline powder containing small amounts of sorbitol and related polyhydric alcohols. It is very soluble in water and slightly soluble in ethanol.
Function: Sweetener; humectant; stabilizer.

REQUIREMENTS
Identification: To pass the test by thin-layer chromatography
Assay: Not less than 92.0% and not more than 100.5% of D-maltitol as C12H24O11, calculated on the dried basis.
Lead: Not more than 1 mg/kg.
Nickel: Not more than 1 mg/kg.
Other Hydrogenated Saccharides: Not more than 7.0%.
Reducing Sugars (as glucose): Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.
Water: Not more than 1.5%.

We also supply Maltitol & Maltitol Solution Syrup of BP Ph Eur grade.

Please visit SDS Safety Data Sheet of Maltitol & Maltitol Solution 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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Suppliers and Manufacturers' Representative:
American Molecules - Ammol.org USA
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org