Items | Specification |
Appearance | A Colorless or slightly yellowish,viscous hygroscopic liquid (may crystallized on storage) |
Solubility | Very soluble in water, freely soluble in ethanol (96per cent) and practically insoluble in heptane |
Identification | Complies with the test for specific optical rotation |
Infrared Absorption | IR spectrum |
TLC | TLC Chromatogram |
Appearance of Solution | Clear and not more intensely coloured than reference solution B6 |
pH | ≤ 10.5 |
Specific Optical Rotation | +29.0~+32.0° |
Impurity A and Other Amino Compounds | ≤ 1.0% |
Related Substances |
|
Impurity C | ≤ 1.0% |
Impurity B | ≤ 0.5% |
Unspecified Impurities (for each impurity) | ≤ 0.10% |
Total | ≤ 2.0% |
Water (Karl Fischer Method) | ≤ 1.0% |
Sulfated Ash | ≤ 0.1% |
Assay | 98.0%~ 101.0% (Titration) |
Additional Tests |
|
Heavy Metals | ≤ 20 ppm |
Formaldehyde | ≤ 5 ppm |
Total Aerobic Microbial Count (TAMC) | ≤ 100 CFU/g |
Total Combined Yeasts (TYMC) | ≤ 10 CFU/g |
Standard | In House |