| Tests | | Specifications | | Reference |
| Description | | White or slightly yellowish, crystalline powder | | EP |
| | | | |
| Solubility | | Freely soluble in water, practically insoluble in ethanol (96 %)
| | EP |
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| Identification | |
| | EP |
| | | | |
| First Identification A,B,E
| | | | EP |
| | | | |
| Second Identification A,C,D,E | | | | EP |
| | | | |
| A.Specific optical rotation (dried substance)
| | + 95.0º to + 97.0º
| | EP |
| | | | |
| B.Infrared absorption
spectrophotometry
| | Shall pass the test | | EP |
| | | | |
| C.Test C | | 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 | | Clear and not more intensely coloured than reference solution Y6 | | EP |
| | | | |
| pH
| | 6.8 to 7.4 | | EP |
| | | | |
| Specific optical rotation (dried substance) | | + 95.0º to + 97.0º | | EP |
| | | | |
| Fluorides | | Max. 10 ppm | | EP |
| | | | |
| Copper
| | Max. 5 ppm
| | EP |
| | | | |
| Iron
| | Max. 2 ppm
| | EP |
| | | | |
| Heavy metals | | Max. 10 ppm | | EP |
| | | | |
| Loss on drying | | Max. 0.1% | | EP |
| | | | |
| Assay as C12H14CaO12 .2H2O | | 99.0 % to 100.5% | | 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.
|
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