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