Edition: BP 2025 (Ph. Eur. 11.6 update)
General Notices
DEFINITION
Barium Sulfate Oral Suspension is a suspension of Barium Sulfate for Suspension in a suitable aqueous vehicle.
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.
Content of barium sulfate, BaSO4
90.0 to 110.0% of the stated amount.
CHARACTERISTICS
A smooth, white or creamy white suspension.
IDENTIFICATION
Evaporate 1 mL to dryness and ignite to constant weight. The residue complies with the following tests.
A. To 0.2 g add 5 mL of a 50% w/v solution of sodium carbonate and boil for 5 minutes, add 10 mL of water and filter. Reserve the residue for test B. Acidify the filtrate with 2M hydrochloric acid. The resulting solution yields the reactions characteristic of sulfates, Appendix VI.
B. Wash the residue reserved in test A with water, add 5 mL of 2M hydrochloric acid, mix well and filter. Add 0.3 mL of 1M sulfuric acid to the filtrate. A white precipitate is produced which is insoluble in 2M hydrochloric acid.
Acidity or alkalinity
pH, 3.5 to 8.5, Appendix V L.
ASSAY
Evaporate to dryness a quantity containing 0.6 g of Barium Sulfate in a platinum dish on a water bath and carry out the Assay described under Barium Sulfate for Suspension, beginning at the words ‘add 5 g of sodium carbonate…’. Determine the weight per mL of the oral suspension, Appendix V G, and calculate the percentage of BaSO4, weight in volume.
