| Calcium Gluconate for Injection EP |
| Product name | : | Calcium Gluconate for Injection EP |
| CAS No. | : | 18016-24-5 |
| Molecular Formula | : | C12 H22 CaO14. H2O |
| Molecular Weight | : | 448.4 |
| Tests | | Specifications | | Reference |
| Characters
| | White or almost white, crystalline or granular powder | | EP |
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| Solubility | | Sparingly soluble in water, freely soluble in boiling
water
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| Identification | | | | EP |
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| A.Thin-layer chromatography
| | Shall pass the test | | EP |
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| B.Reaction of calcium
| | Shall pass the test | | EP |
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| 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
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| pH
| | 6.4 to 8.3 | | EP |
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| Organic impurities and boric Acid | | Shall pass the test | | EP |
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| Oxalates
| | Max. 100 ppm | | EP |
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| Sucrose & reducing sugars | | No red precipitate is formed | | EP |
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| Chlorides
| | Max. 50 ppm | | EP |
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| Phosphates
| | Max. 100 ppm | | EP |
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| Sulphates
| | Max. 50 ppm | | EP |
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| Iron
| | Max. 5 ppm
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| Magnesium & alkali Metals | | Max. 0.4 % | | EP |
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| Heavy metals
| | Max. 10 ppm
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| Assay as C12 H22 CaO14.H2O | | 99.0 % - 101.0 % | | EP |
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| Bacterial endotoxins | | Less than 167 IU / g | | EP |
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| Calcium Gluconate for Injection EP |
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| Total viable aerobic count
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Max. 10^2 CFU/g | | EP |
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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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| Retest Period: | | 5 years from the date of manufacture. |
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