| Tests | | Specifications | | Reference |
| Characters | | White or almost white powder, slightly hygroscopic
| | EP |
| | | | |
| Solubility
| | Freely soluble in water, slightly soluble in alcohol
| | EP |
| | | | |
| Identification | | | | EP |
| | | | |
| A.Specific optical rotation
(dried substance)
| | Shall pass the test | | EP |
| | | | |
| B.Thin-layer chromatography
| | Shall pass the test | | EP |
| | | | |
| C.Test C
| | Shall pass the test | | EP |
| | | | |
| D.Reaction of calcium | | Shall pass the test | | EP |
| | | | |
| Appearance of solution | | Clear & colourless | | EP |
| | | | |
| pH
| | 6.8 to 8.0
| | EP |
| | | | |
| Specific optical rotation (dried substance)
| | +25.5° to +27.5° | | EP |
| | | | |
| Chlorides
| | Not more than 200 ppm | | EP |
| | | | |
| Heavy metals
| | Not more than 20 ppm
| | EP |
| | | | |
| Loss on drying | | Not more than 3.0 % | | EP |
| | | | |
| Assay as C18 H32CaN2O10 (On dried substance)
| | 98.0% - 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: | | 3 years from the date of manufacture |
| | |