| Tests | | Specifications | | Reference |
| Appearance | | White to slightly yellow, practically odourless powder. | | USP |
| | | | |
| Solubility
| | Freely soluble in water, Slightly soluble in
alcohol,insoluble in
ether.
| | USP |
| | | | |
| Identification | | | | USP |
| | | | |
| A.Test for Calcium
| | Shall pass the test | | USP |
| | | | |
| B.Test B
| | Shall pass the test | | USP |
| | | | |
| C.Infrared Absorption | | Shall pass the test | | USP |
| | | | |
| Specific rotation | | Between + 95.0º to + 97.0º | | USP |
| | | | |
| pH
| | Between 6.8 and 7.4
| | USP |
| | | | |
| Loss on drying | | Not more than 0.1% | | USP |
| | | | |
| Arsenic
| | Max. 3 µg / g
| | USP |
| | | | |
| Heavy metals | | Max. 0.001% | | USP |
| | | | |
| Limit of fluoride | | Max. 10 ppm | | USP |
| | | | |
| Assay as C12H14CaO12.2H2O (On as-is basis)
| | 98.0 % to 101.0 % | | USP |
| | | | |
| | |
| 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.
|
| | |