Packaging and storage— Preserve in tight containers,protected from freezing and from excessive heat.

Identification— Ignite an accurately weighed quantity of Paste,equivalent to about 0.5g of barium sulfate,to constant weight:the ignited residue meets the requirements for Identificationtests Aand Bunder Barium Sulfate.

Microbial limits á61ñ— For products labeled for oral administration or labeled for oral and rectal administration,the total aerobic microbial count does not exceed 100cfu per g,and the total combined molds and yeasts count does not exceed 10cfu per g.For products labeled for rectal administration,the total aerobic microbial count does not exceed 1000cfu per g,and the total combined molds and yeasts count does not exceed 100cfu per g.For all products,it meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,Staphylococcus aureus,and Pseudomonas aeruginosa,and the total enterobacterial count does not exceed 10cfu per g.

pHá791ñ: between 3.0and 10.0.

Assay— Using Paste,proceed as directed in the Assayunder Barium Sulfate for Suspension.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 220

Phone Number:1-301-816-8305