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 0.5 g of barium sulfate, to constant weight: the ignited residue meets the requirements for Identification tests A and B under Barium Sulfate.

Microbial limits 61— For products labeled for oral administration or labeled for oral and rectal administration, the total aerobic microbial count does not exceed 100 cfu per g, and the total combined molds and yeasts count does not exceed 10 cfu per g. For products labeled for rectal administration, the total aerobic microbial count does not exceed 1000 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g. For all products, it meets the requirements of the tests for absence of Salmonella species, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, and the total enterobacterial count does not exceed 10 cfu per g.

pH 791: between 3.0 and 10.0.

Residual solvents 467: meets the requirements.

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

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 240

Phone Number : 1-301-816-8305