INTRODUCTION
Calcium Gluconate is the calcium salt of gluconic acid, an oxidation product of glucose, and contains 9.3% calcium, which is about one-third of the calcium in the strength of calcium chloride. It is an ingredient found in a variety of supplements and vitamins and is used to lower potassium in the blood. Calcium gluconate is used as a mineral supplement and medication when there is insufficient calcium in the diet. Supplementation may be done to treat or prevent osteoporosis or rickets, consequences of hypocalcemia.
Manufacture
It is made by mixing gluconic acid with calcium carbonate or calcium hydroxide
| Synonyms | Calcium di-(D-gluconate) D-Gluconic acid calcium salt |
| CAS no. | 299-28-5 |
| EINECS no. | 206-075-8 |
| Molecular formula | C12H22CaO14 |
| Molecular weight | 430.37 |
| Structure |  |
Applications
| Calcium gluconate is used to prevent or treat calcium deficiencies. Oral calcium salts are used as dietary supplemental therapy for people who may not get enough calcium in their regular diet |
| Calcium gluconate is used as a cardioprotective agent in high blood potassium |
| Calcium gluconate is the antidote for magnesium sulfate toxicity |
Calcium gluconate is also used as/for:
| Hyperkalemia |
| Hypocalcemia tetany |
| Dietary Supplement |
| Hungry Bone Syndrome |
| Tumor Lysis Syndrome |
SPECIFICATIONS – for injection, EP
| Test | Unit | Specification |
|---|---|---|
| Appearance | – | White or almost white, crystalline or granular powder |
| Solubility | – | Sparingly soluble in water, freely soluble in boiling water |
| Identification A. TLC B. Reaction of Calcium | – – | Shall pass the test Shall pass the test |
| Appearance of solution | – | At 60°C, solution S is not more intensely colored than reference solution B7. After cooling to 20°C, it is not more opalescent than reference suspension II. |
| pH | – | Between 6.4 and 8.3 |
| Organic impurities & Boric acid | – | Shall pass the test |
| Oxalates | ppm | Max 100 |
| Sucrose & reducing sugars | – | No red precipitate is formed |
| Chlorides | ppm | Max 50 |
| Phosphates | ppm | Max 100 |
| Sulphates | ppm | Max 50 |
| Iron | ppm | Max 5 |
| Magnesium & alkali metals | % | Max 0.4 |
| Assay as C12H22CaO14H2O | % | Between 99.0 and 101.0 |
| Microbial Contamination | ||
| Bacterial endotoxins | IU/g | Max 167 |
| Total aerobic microbial count | CFU/g | Max 10(square) |
STORAGE
Store in a cool & dry place. Keep away from moisture.
PACKING
25 kg drum.
REGISTRATION / CERTIFICATION
US-DMF, CEP, EU-GMP, EU-WC (Written Confirmation)
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