| Tests | | Specifications | | Reference |
| Appearance | | White or almost white, crystalline powder | | EP |
| | | | |
| Solubility | | Freely soluble in water and
dimethylformamide, practically insoluble in
acetone and in anhydrous methanol.
| | EP |
| | | | |
| Identification | | | | EP |
| | | | |
| First Identification B, E | | | | EP |
| | | | |
| Second Identification A, C, D, E | | | | EP |
| | | | |
| A.Ultraviolet and visible
absorption spectrophotometry
| | Shall pass the test | | EP |
| | | | |
| B.Infrared absorption
spectrophotometry
| | Shall pass the test | | EP |
| | | | |
| C.Reaction of Salicylates | | Shall pass the test | | EP |
| | | | |
| D.Test D | | Shall pass the test | | EP |
| | | | |
| E.Reaction of calcium | | Shall pass the test | | EP |
| | | | |
| Appearance of solution | | Not more opalescent than reference suspension II and is colourless
| | EP |
| | | | |
| Related substances | | | | EP |
| | | | |
| A.Impurity C | | Not more than 0.5 % | | EP |
| | | | |
| B.Impurity B | | Not more than 0.15% | | EP |
| | | | |
| C.Unspecified impurities | | Not more than 0.05% | | EP |
| | | | |
| D.Total impurities | | Not more than 0.7% | | EP |
| | | | |
| Sodium
| | Max. 0.10 % | | EP |
| | | | |
| Heavy metals
| | Max. 10 ppm
| | EP |
| | | | |
| Water
| | Max. 0.1% | | EP |
| | | | |
| Assay as C19 H18 CaN2O9
(anhydrous 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 |
| | |