Lactobionic Acid

EP, Injectable Grade

CAS #:

96-82-2

Molecular Formula:

C12H22O12

Synonym:

4-O-β-D-Galactopyranosyl-D-gluconic acid

Molecular Weight:

358.29 g/mol

Overview

Lactobionic Acid, EP is also known as Galactosylgluconic acid. It is a food additive used as a stabilizer and in the pharmaceutical industry as an excipient for formulation. The EP grade indicates it is grade suitable for personal care, cosmetic and pharmaceutical applications.

Characters Unit Specification
Identity A [EP (2.2.24)] IR
Identity B [EP (2.2.27)] TLC
Appearance White microcryst. solid
Solubility [EP] Freely soluble in water; slightly soluble in glacial Acetic acid, in anhydrous Ethanol & Methanol
Clarity [EP] The solution is clear (2.2.1) and not more intensely colored than reference solution Y5 (2.2.2, Method II)
Assay [EP (2.2.20)] % 98-102
Sp. Rot., [α]D [EP (2.2.7)] +23.0° - +29.0° (H2O)
Water [EP (2.5.12)] % < 5
pH 1.0 – 3.0
Reducing Sugars [EP] % ≤ 0.2
Total Ash [EP (2.4.16)] % ≤ 0.2
Calcium ppm ≤ 500
Chloride ppm ≤ 500
Sulfate ppm ≤ 500
Heavy metals [EP 2.4.8)] ppm ≤ 20
Endotoxin Level EU/g < 10
Microbiological Specifications
Total Aerobic CFU/g < 100 organisms/g
E Coli Negative
Salmonella Negative
Pseudomonas aeruginosa Negative
Mold & Yeast CFU/g < 10 organisms/g

Shelf Life/Retest Date: The minimal shelf-life of Lactobionic Acid, CAS 96-82-2 is 2 years when stored under recommended conditions.

Storage/Shipping Conditions:

  • Store at room temperature in the original container.
  • Keep container tightly closed in a cool, dry, dark containment.
  • Store away from incompatible materials.

Pack Sizes: 5 Kg

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