Edition: BP 2025 (Ph. Eur. 11.6 update)
NOTE: This monograph has been developed to cover unlicensed formulations.
Action and use
Phosphate binder; treatment of hyperphosphataemia.
DEFINITION
Calcium Carbonate Oral Suspension is a suspension of Calcium Carbonate in a suitable vehicle.
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements. Where appropriate, the oral suspension also complies with the requirements stated under Unlicensed Medicines.
Content of calcium carbonate, CaCO3
90.0 to 110.0% of the stated amount.
IDENTIFICATION
It may be necessary to add a drop of a suitable antifoaming agent to a volume of the oral suspension before carrying out the following tests.
A. Mix 1 volume of the oral suspension with 1 volume of water and filter. The filtrate yields reaction C characteristic of calcium salts, Appendix VI.
B. Dilute a volume of the oral suspension containing 0.6 g of Calcium Carbonate to 2 volumes with 2M hydrochloric acid. The resulting solution yields reaction A characteristic of carbonates, Appendix VI.
TESTS
Acidity or alkalinity
pH 7.0 to 8.7, Appendix V L.
Dissolution
Complies with the requirements stated under Unlicensed Medicines, Oral Suspensions. Use a volume of the oral suspension containing one dose.
ASSAY
It may be necessary to add one or two drops of a suitable antifoaming agent to the oral suspension before carrying out the Assay.
To a weighed quantity of the oral suspension containing 0.15 g of Calcium Carbonate add 3 mL of dilute hydrochloric acid and 20 mL of water. Boil for 2 minutes, allow to cool and dilute to 50 mL with water. Carry out the complexometric titration of calcium, Appendix VIII D. Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of CaCO3, weight in volume.
Each mL of 0.1M sodium edetate is equivalent to 10.01 mg of CaCO3.
