American Molecules - USA

Lactobionic Acid USP NF Grade Supplier Exporter Manufacturers' Representative

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Lactobionic Acid
CAS Number: 96-82-2

Molecular Formula: C12H22O12
Molecular Weight: 358.30

Lactobionic Acid Suppliers
Lactobionic Acid

Lactobionic Acid USP NF Grade Specifications:
C12H22O12 (acid form) --- 358.30 --- CAS 96-82-2.
C12H20O11 (δ-lactone) 340.28 CAS 5965-65-1
4-O-β-Galactopyranosyl-d-gluconic acid.
UNII: 65R938S4DV

Lactobionic Acid is a mixture in variable proportions of 4-O-β-d-galactopyranosyl-d-gluconic acid and 4-O-β-d-galactopyranosyl-d-glucono-1,5-lactone. It contains 98% toT 102%, on the anhydrous basis.

Infrared Absorption: [Note— If the spectra obtained show differences, dissolve the test substance and USP Lactobionic Acid RS separately in water, dry at 105C, and record new spectra using the residues. ]
B. Thin-Layer Chromatography: Acceptance criteria: The principal spot from the Sample solution is similar in position and color to the principal spot from the Standard solution.

Sample: 0.350 g of Lactobionic Acid
Analysis:Dissolve the Sample in 50 mL of carbon dioxide-free water, previously heated to 30C. Immediately titrate with 0.1 N sodium hydroxide and determine the two equivalence points potentiometrically.
Each mL of 0.1 N sodium hydroxide consumed to the first equivalency point is equivalent to 35.83 mg of C12H22O12 (corresponds to the acid form), and each mL of 0.1 N sodium hydroxide consumed between the first and second equivalency points is equivalent to 34.03 mg of C12H20O11 (corresponds to the δ-lactone form).
Calculate the content, expressed as a percentage, of the lactobionic acid as the sum of both results.
Acceptance criteria: 98.0%–102.0% on the anhydrous basis

Water Determination
Acceptance criteria: 5.0% maximum.
Appearance of Solution
Sample solution: 120 mg/mL of Lactobionic Acid
Standard stock solution: Pipet 24.0 mL of ferric chloride CS and 6.0 mL of cobaltous chloride CS into a 100-mL volumetric flask. Dilute with 1% (w/v) hydrochloric acid to volume.
Reference solution: Pipet 12.5 mL of the Standard stock solution into a 100-mL volumetric flask. Dilute with 1% (w/v) hydrochloric acid to volume.
Acceptance criteria: The Sample solution is clear and not more intensely colored than the Reference solution.
Optical Rotation
Sample solution: 10 mg/mL of Lactobionic Acid. Allow to stand for 24 h.
Acceptance criteria: +23.0° to +29.0° (anhydrous substance).
Reducing Sugars
Sample solution: Dissolve 5.0 g of Lactobionic Acid in 25 mL of water with the aid of gentle heat, and cool.
Analysis: To the Sample solution add 20 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 100 mL of a 2.4% solution of glacial acetic acid and 20.0 mL of 0.025 M 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 iodine with 0.05 M sodium thiosulfate VS using 1 mL of starch TS, added toward the end of the titration as an indicator.
Acceptance criteria: NLT 12.8 mL of 0.05 M sodium thiosulfate is required, corresponding to NMT 0.2% of reducing sugars, as glucose.
Articles of Botanical Origin: 0.2% maximum.

Please visit SDS Safety Data Sheet of Lactobionic Acid Suppliers.

American Molecules, also known as 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 - USA
6903 Gossamer Ln, Sugar Land, Texas, USA 77479
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665