Calcium Gluconate for Injection EP
| Product Name: | Calcium Gluconate for Injection EP |
| Product Formula: | C12 H22 CaO14. H2O |
| Molecular Weight: | 448.4 |
| CAS Number: |
| No. | Tests | Specifications | Reference |
|---|---|---|---|
| 1 | Characters | White or almost white, crystalline or granular powder | EP |
| 2 | Solubility | Sparingly soluble in water, freely soluble in boiling water | EP |
| 3 | Identification : A . Thin-layer chromatography B. Reactions of calcium. |
Shall pass the test Shall pass the test |
EP |
| 4 | Appearance of solution | Not more intensely coloured than reference solution B7.After cooling to 20°C, it is not more opalescent than reference suspension II. | EP |
| 5 | pH | 6.4 to 8.3 | EP |
| 6 | Organic impurities and boric Acid | Shall pass the test | EP |
| 7 | Oxalates | Max. 100 ppm | EP |
| 8 | Sucrose & reducing sugars | No red precipitate is formed | EP |
| 9 | Chlorides | Max. 50 ppm | EP |
| 10 | Phosphates | Max. 100 ppm | EP |
| 11 | Sulphates | Max. 50 ppm | EP |
| 12 | Iron | Max. 5 ppm | EP |
| 13 | Magnesium & alkali Metals | Max. 0.4 % | EP |
| 14 | Heavy Metals | Max. 10 ppm | EP |
| 15 | Assay as C12 H22 CaO14.H2O | 99.0 % - 101.0 % | EP |
| 16 | Bacterial endotoxins | Less than 167 IU / g | EP |
| 17 | Microbial contamination Total viable aerobic count | Max. 102 CFU/ g | 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:5 years from the date of manufacture.
