| Tests | | Specifications | | Reference |
| Appearance
| | White or almost white, crystalline powder
| | BP |
| | | | |
| Solubility
| | Freely soluble in water and dimethylformamide, practically insoluble in
acetone and in anhydrous methanol
| | BP |
| | | | |
| Identification | | | | BP |
| | | | |
| First Identification B, E
| | | | BP |
| | | | |
| Second Identification A, C, D, E | | | | BP |
| | | | |
| A.Ultraviolet and visible
absorption
spectrophotometry
| | Shall pass the test | | BP |
| | | | |
| B.Infrared absorption
spectrophotometry
| | Shall pass the test | | BP |
| | | | |
| C.Reaction of Salicylates | | Shall pass the test | | BP |
| | | | |
| D.Test D | | Shall pass the test | | BP |
| | | | |
| E.Reaction of calcium | | Shall pass the test | | BP |
| | | | |
| Appearance of solution | | Not more opalescent than reference suspension II and is colorless
| | BP |
| | | | |
| Related substances | |
| | BP |
| | | | |
| A.Impurity C | | Not more than 0.5 % | | BP |
| | | | |
| B.Impurity B | | Not more than 0.1 % | | BP |
| | | | |
| Sodium
| | Max. 0.10 %
| | BP |
| | | | |
| Heavy metals
| | Max. 10 ppm
| | BP |
| | | | |
| Water
| | Max. 0.1%
| | BP |
| | | | |
| Assay as C19 H18 CaN2O9
(anhydrous substance)
| | 99.0% - 101.0% | | BP |
| | | | |
| | |
| 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 |
| | |