DEFINITION
Calcium Borogluconate Injection is a sterile solution of Calcium Gluconate and Boric Acid in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of calcium, Ca
95.0 to 105.0% of the stated amount.
Content of boric acid, H3BO3
Not more than 2.3 times the stated content of calcium.
IDENTIFICATION
A. To 1 mL add sufficient water to produce a solution containing about 0.75% w/v of calcium and add 0.05 mL of iron(III) chloride solution R1. An intense yellow or yellowish green colour is produced.
B. Yields the reactions characteristic of calcium salts, Appendix VI.
C. To 1 mL add 0.15 mL of sulfuric acid and 5 mL of methanol and ignite. The mixture burns with a flame tinged with green.
Acidity
pH of the injection, diluted if necessary with carbon dioxide-free water to contain 1.5% w/v of calcium, 3.0 to 4.0, Appendix V L.
ASSAY
For calcium
Dilute a quantity containing the equivalent of 45 mg of calcium to about 50 mL with water. Titrate with 0.05M disodium edetate VS to within a few mL of the expected end point, add 4 mL of a 40% w/v solution of sodium hydroxide and 10 mg of solochrome dark blue mixture and continue the titration until the colour changes from pink to blue. Each mL of 0.05M disodium edetate VS is equivalent to 2.004 mg of Ca.
For boric acid
Dilute a quantity containing 0.1 g of Boric Acid to 50 mL with water, add 3 g of D-mannitol and titrate with 0.1M sodium hydroxide VS using phenolphthalein solution R1 as indicator. Each mL of 0.1M sodium hydroxide VS is equivalent to 6.183 mg of H3BO3.
STORAGE
Calcium Borogluconate Injection should be protected from light. It may be supplied in containers of glass type III, Appendix XIX B.
LABELLING
The strength is stated as the amount of calcium in a suitable dose-volume. The label also states the proportion of boric acid present.
