Calcium Gluconate Injection

Definition

Calcium Gluconate Injection is a sterile solution of Calcium Gluconate for Injection in Water for Injections. Not more than 5.0% of the Calcium Gluconate may be replaced with calcium m-saccharate, or other suitable calcium salt, as a stabilising agent.

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

Content of calcium, Ca

8.5 to 9.4% of the content of Calcium Gluconate stated on the label.

Identification

A. To 1 mL add 0.05 mL of iron(iii) chloride solution R1. An intense yellow colour is produced.

B. Warm a volume containing the equivalent of 0.5 g of Calcium Gluconate, add 0.65 mL of glacial acetic acid and 1 mL of phenylhydrazine. Heat on a water bath for 30 minutes, allow to cool and induce crystallisation. Filter, dissolve the residue in 10 mL of hot water, add a few mg of activated charcoal, shake, filter, allow the filtrate to cool and induce crystallisation. A white, crystalline precipitate is produced. The melting point of the crystals, after drying, is about 200°, with decomposition, Appendix V A.

C. Yields the reactions characteristic of calcium salts, Appendix VI.

Test

Bacterial endotoxins

Carry out the test for bacterial endotoxins, Appendix XIV C. Dilute the injection in water BET if necessary to give a solution containing 100 mg of Calcium Gluconate per millilitre (solution A). The endotoxin limit concentration of solution A is 16.7 IU per mL.

Assay

To a volume containing the equivalent of 0.5 g of Calcium Gluconate add 300 mL of water and carry out the complexometric titration of calcium, Appendix VIII D, beginning at the words ‘add 6 mL of ...’.

Labelling

The label states (1) the percentage w/v of Calcium Gluconate equivalent to the total amount of calcium present; (2) that solutions containing visible solid particles must not be used; (3) the name and the percentage of any added stabilising agent.