| Calcium Levulinate dihydrate EP-BP for Inj |
| Product name | : | Calcium Levulinate dihydrate EP-BP for Inj |
| CAS No. | : | 5743-49-7 |
| Molecular Formula | : | C10H14CaO6 .2H2O |
| Molecular Weight | : | 306.3 |
| Tests | | Specifications | | Reference |
| Description
| | White or almost white, crystalline powder | | EP/BP |
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| Solubility | | Freely soluble in water, very slightly soluble in ethanol(96 %),practically insoluble in methylene chloride
| | EP/BP |
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| Identification | | | | EP/BP |
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| First Identification A,D,E
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| Second Identification B, C, D, E
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| A.Infrared absorption
spectrophotometry
| | Shall pass the test | | EP/BP |
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| B.Thin-layer chromatography
| | Shall pass the test | | EP/BP |
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| C.Melting point
| | 203 º C to 210 º C | | EP/BP |
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| D.Reaction of calcium
| | Shall pass the test | | EP/BP |
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| E.Loss on drying
| | 11.0 % - 12.5 % | | EP/BP |
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| Appearance of solution | | Clear and not more intensely coloured than reference solution Y6.
| | EP/BP |
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| pH
| | 6.8 to 7.8 | | EP/BP |
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| Oxidisable substances
| | Shall pass the test | | EP/BP |
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| Sucrose and reducing sugars | | Shall pass the test | | EP/BP |
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| Chlorides
| | Max. 50 ppm
| | EP/BP |
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| Sulphates
| | Max. 200 ppm | | EP/BP |
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| Magnesium and alkali metals
| | Max. 1.0 % | | EP/BP |
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| Heavy metals
| | Max. 10 ppm | | EP/BP |
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| Loss on drying
| | 11.0 % - 12.5 % | | EP/BP |
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| Bacterial Endotoxins * | | Max 167 EU/g | | EP/BP |
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| Assay as C10H14CaO6 (On dried substance)
| | 98.0 % - 101.0 % | | EP/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 |
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