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Barium Sulfate Suspension
» Barium Sulfate Suspension contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of barium sulfate (BaSO4). It contains suitable dispersing and/or suspending agents so that when mixed as directed in the labeling, it yields a uniformly dispersed suspension. It may contain one or more suitable colors, flavors, fluidizing agents, and preservatives.
Packaging and storage— Preserve in tight containers, and avoid freezing.
Identification— Shake the Suspension, and transfer a volume equivalent to 0.5 g of barium sulfate to a suitable container. Ignite to constant weight: the ignited residue meets the requirements for the Identification tests under Barium Sulfate.
Microbial limits 61— The total bacterial count does not exceed 100 cfu per mL; the total combined molds and yeasts count does not exceed 10 cfu per mL; and it meets the requirements of the tests for absence of Salmonella species, Staphylococcus aureus, and Pseudomonas aeruginosa.
pH 791: between 3.5 and 10.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Using an accurately measured volume of Suspension, previously well shaken in its original container, equivalent to about 0.60 g of BaSO4, proceed as directed in the Assay under Barium Sulfate for Suspension.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 240
Pharmacopeial Forum : Volume No. 28(1) Page 38
Phone Number : 1-301-816-8305