Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
Calcium Chloride Injection is a sterile solution of Calcium Chloride Dihydrate in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of calcium chloride dihydrate, CaCl2,2H2O
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. 1 mL yields reaction C characteristic of calcium salts, Appendix VI.
B. Dilute 1 volume of the injection to 50 mL with water. The resulting solution yields reaction A characteristic of chlorides, Appendix VI.
TESTS
Acidity or alkalinity
pH 5.0 to 8.0, Appendix V L.
Colour of solution
The injection is not more intensely coloured than reference solution BY6, Appendix IV B, Method II.
ASSAY
Carry out the complexometric titration of calcium, Appendix VIII D. Use a volume of the injection containing about 0.3 g of Calcium Chloride Dihydrate. Each mL of 0.1M sodium edetate is equivalent to 14.70 mg of CaCl2,2H2O.
LABELLING
The label states (1) the percentage w/v of Calcium Chloride Dihydrate; (2) the concentration of calcium ion as millimoles in a suitable volume; (3) the concentration of chloride ion as millimoles in a suitable volume; (4) that solutions containing visible solid particles must not be used.
When calcium chloride intravenous infusion is prescribed or demanded, Calcium Chloride Injection shall be dispensed or supplied.
