Lactobionic Acid
| Product Name: | Lactobionic Acid |
| Product Formula: | C12 H22 O12 – Acid Form C12 H20 O11 – d–Lactone |
| Molecular Weight: | Acid Form - 358.3 d–Lactone - 340.3 |
| CAS Number: | Acid form - 96-82-2 d-lactone - 5965-65-1 |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Description | White or almost white powder | Eur. Ph 6.0 |
| 2 | Solubility | Freely soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol. |
Eur. Ph 6.0 |
| 3 | Melting point | About 125°C with decomposition | Eur. Ph 6.0 |
| 4 | Identification A. Infrared Absorption Spectrophotometry B. TLC |
Shall pass the test Shall pass the test |
Eur. Ph 6.0 |
| 5 | Appearance of solution (Dissolve 3.0g in 25ml of water R) |
The solution is clear and not more intensely coloured than reference solution Y6 | Eur. Ph 6.0 |
| 6 | Specific optical rotation (anhydrous substance) |
+ 23.0 to 29.0 | Eur. Ph 6.0 |
| 7 | Reducing sugars (Calculated as glucose) |
Max. 0.2 % | Eur. Ph 6.0 |
| 8 | Heavy metals | Max. 20 ppm | Eur. Ph 6.0 |
| 9 | Water | Max. 5.0 % | Eur. Ph 6.0 |
| 10 | Total ash | Max. 0.2 % | Eur. Ph 6.0 |
| 11 | Assay (Anhydrous substance) | 98.0 % - 102.0 % | Eur. Ph 6.0 |
| 12 | Additional Tests | ||
| 13 | pH of 10 % w/v solution in water | 1.0 – 3.0 | As per EP * |
| 14 | Microbial Contamination | ||
| 15 | Bacterial Endotoxin Test | Max. 50 EU/g | As per EP * |
| 16 | Total aerobic microbial count | Max. 100 CFU/g | As per EP * |
| 17 | Enterobacteriaceae | To be absent in 1g | As per EP * |
| 18 | E. coli | To be absent in 10g | As per EP * |
| 19 | Salmonella sp. | To be absent in 10g | As per EP * |
| 20 | Pseudomonas aeruginosa | To be absent in 10g | As per EP * |
| 21 | Coagulase Positive Staphylococcus Aureus | To be absent in 10g | As per EP * |
* Testing Methods are adapted from the General chapters of European Pharmacopoeia 6.0
Storage: Recommended to store in a well-closed container, protected from direct sunlight and moisture.
Retest Period: 3 years from the date of manufacture
