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
