Packaging and storage
Preserve in well-closed containers.
Microbial limits
Collect aseptically in a suitable container about 1 g from not less than 5 containers, dissolve in 500 mL of
Fluid A, filter through a membrane filter as directed for
Membrane Filtration under
Test for Sterility of the Product to be Examined under
Sterility Tests 71, except to place the filter on the surface of SoybeanCasein Digest Agar Medium in a Petri dish, incubate for 7 days at 30
to 35
, and count the number of colonies on the filter. Similarly prepare a second specimen, except to incubate at 20
to 25
. Not more than 20 colonies are observed from the two specimens. It meets also the requirements of the tests for absence of
Staphylococcus aureus and
Pseudomonas aeruginosa under
Microbial Limit Tests 61.
Assay for polymyxin B
Proceed as directed for polymyxin B under
AntibioticsMicrobial Assays 81, using an accurately weighed portion of Topical Powder, equivalent to about 5000 USP Polymyxin B Units, shaken with 20 mL of water in a suitable volumetric flask. Dilute with
Buffer No. 6 to volume, and mix. Dilute an accurately measured volume of the solution so obtained quantitatively with
Buffer No. 6 to obtain a
Test Dilution having a concentration of polymyxin B assumed to be equal to the median dose level of the Standard.
Assay for bacitracin
Proceed as directed for bacitracin under
AntibioticsMicrobial Assays 81, using an accurately weighed portion of Topical Powder, equivalent to about 800 USP Bacitracin Units, added to a 100-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Dilute this solution quantitatively with
Buffer No. 1 to obtain a
Test Dilution having a concentration assumed to be equal to the median dose level of the Standard. In preparing each test dilution of the Standard, add additional hydrochloric acid to each to obtain the same concentration of hydrochloric acid as in the
Test Dilution.