Calcium Levulinate Dihydrate EP-BP (for Injection)
| Product Name: | Calcium Levulinate Dihydrate EP-BP (for Injection) |
| Product Formula: | C10H14CaO6 .2H2O |
| Molecular Weight: | 306.3 |
| CAS Number: | 5743-49-7 |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Description | White or almost white, crystalline powder | EP/BP |
| 2 | Solubility | Freely soluble in water, very slightly soluble in ethanol (96 %), practically insoluble in methylene chloride | EP/BP |
| 3 | Identification : First Identification A, D, E Second Identification B, C, D, E A. Infrared absorption Spectrophotometry B. Thin-layer chromatography C. Melting point D . Reaction of calcium E . Loss on drying |
Shall pass the test Shall pass the test 203 º C to 210 º C Shall pass the test 11.0 % to 12.5 % |
EP/BP |
| 4 | Appearance of solution | Clear and not more intensely coloured than reference solution Y6 | EP/BP |
| 5 | pH | 6.8 to 7.8 | EP/BP |
| 6 | Oxidisable substances | Shall pass the test | EP/BP |
| 7 | Sucrose and reducing sugars | Shall pass the test | EP/BP |
| 8 | Chlorides | Max. 50 ppm | EP/BP |
| 9 | Sulphates | Max. 200 ppm | EP/BP |
| 10 | Magnesium and alkali metals | Max. 1.0 % | EP/BP |
| 11 | Heavy metals | Max. 10 ppm | EP/BP |
| 12 | Loss on drying | 11.0 % - 12.5 % | EP/BP |
| 13 | Bacterial Endotoxins * | Max 167 EU/g | EP/BP |
| 14 | Assay as C10H14CaO6 (dried substance) | 98.0 % - 101.0 % | EP/BP |
* Pyrogens test is replaced with Bacterial Endotoxin test
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: 3 years from the date of manufacture.
