| Tests | | Specifications | | Reference |
| Appearance | | White powder, slightly hygroscopic. | | IP |
| | | | |
| Solubility | | Freely soluble in water, soluble in glycerin;
slightly soluble in ethanol (95 %); practically
insoluble in ether
| | IP |
| | | | |
| Identification
A. Test for ß-Alanine
B. Test B
C. Test C
D. Reaction of calcium salts
| | Shall pass the test
Shall pass the test
Shall pass the test
Shall pass the test
| | IP |
| | | | |
| Appearance of the solution | | Clear and colorless | | IP |
| | | | |
| pH | | 6.8 to 8.0 | | IP |
| | | | |
| Specific optical rotation | | +25.0° to +27.5° | | IP |
| | | | |
| ß-Alanine | | Shall pass the test | | IP |
| | | | |
| Heavy metals | | Max. 20 ppm | | IP |
| | | | |
| Loss on drying | | Not more than 3.0 % | | IP |
| | | | |
| Assay as C18H32CaN2O10 (On dried basis) | | 98.0% - 101.0% | | IP |
| | | | |
| | |
| Storage: | | Store in a well-closed container at a temperature not exceeding 25°C, protected from direct sunlight and
Moisture, unless otherwise specified.
|
| | |
| Retest Period: | | 3 years from the date of manufacture |
| | |