Barium Sulfate Suspension
»Barium Sulfate Suspension contains not less than 90.0percent and not more than 110.0percent 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 0.5g of barium sulfate to a suitable container.Ignite to constant weight:the ignited residue meets the requirements for the Identificationtests under Barium Sulfate.
Microbial limits á61ñ— The total bacterial count does not exceed 100cfu per mL;the total combined molds and yeasts count does not exceed 10cfu per mL;and it meets the requirements of the tests for absence of Salmonellaspecies,Staphylococcus aureus,and Pseudomonas aeruginosa.
pHá791ñ: between 3.5and 10.0.
Assay— Using an accurately measured volume of Suspension,previously well shaken in its original container,equivalent to about 0.60g of BaSO4,proceed as directed in the Assayunder Barium Sulfate for Suspension.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 220
Pharmacopeial Forum:Volume No.28(1)Page 38
Phone Number:1-301-816-8305