| Tests | | Specifications | | Reference |
| Appearance | | White or almost white granules or powder | | EP |
| | | | |
| Solubility | | Very soluble in water, practically insoluble in
alcohol and in methylene chloride
| | EP |
| | | | |
| Identification | |
| | EP |
| | | | |
| A. Specific optical rotation (dried
substance)
| | + 25.0º to + 27.0º | | EP |
| | | | |
| B. Infrared absorption spectrophotometry | | Shall pass the test | | EP |
| | | | |
| C. Ninhydrin-positive substances | | Shall pass the test | | EP |
| | | | |
| Appearance of solution | | Clear and not more intensely coloured than reference solution Y7 | | EP |
| | | | |
| pH | | 6.0 – 7.0 | | EP |
| | | | |
| Specific optical rotation (dried substance) | | +25.0° to +27.0° | | EP |
| | | | |
| Ninhydrin-positive substances | | Max. 0.2% | | EP |
| | | | |
| Chlorides | | Max. 200 ppm | | EP |
| | | | |
| Sulphates | | Max. 300 ppm | | EP |
| | | | |
| Ammonium | | Max. 100 ppm | | EP |
| | | | |
| Heavy metals | | Max. 20 ppm | | EP |
| | | | |
| Loss on drying | | Max. 0.5% | | EP |
| | | | |
| Sulphated ash | | Max. 0.1% | | EP |
| | | | |
| Assay as C10 H21 N5 O6 (dried substance) | | 99.0 % - 101.0 % | | EP |
| | | | |
| | |
| 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: | | 2 years from the date of manufacture. |
| | |