|
|
11
—
USP Bacitracin Zinc RS. USP Polymyxin B Sulfate RS.
70
for 16 to 24 hours. Remove the container from the freezer, promptly puncture the container, and allow the propellant to volatilize. Open the container, and mix the contents.
201BNP—
A portion of the contents of 1 container prepared as directed above and tested as directed for Creams, Lotions, and Ointments meets the requirements.
921:
not more than 0.5%, an accurately weighed portion of the contents of 1 container, prepared as directed above, being used, and 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
467:
meets the requirements.
601.
81, using an accurately weighed portion of the contents of 1 container, prepared as directed above, equivalent to about 500 USP Bacitracin Units. Transfer to a suitable separator containing about 50 mL of ether, and extract with three 25-mL portions of Buffer No. 1. Combine the buffer extracts in a 100-mL volumetric flask, dilute with Buffer No. 1 to volume, and mix. Add sufficient 0.01 N hydrochloric acid to an accurately measured volume of this solution so that the amount of hydrochloric acid in the Test Dilution will be the same as in the median dose level of the Standard, and quantitatively dilute with Buffer No. 1 to obtain a Test Dilution having a bacitracin concentration assumed to be equal to the median dose level of the Standard.
81 Transfer an accurately weighed portion of the contents of 1 container, prepared as directed above, equivalent to about 5000 USP Polymyxin B Units, to a suitable separator containing about 50 mL of ether, and extract with three 25-mL portions of Buffer No. 6. Combine the buffer extracts in a 100-mL volumetric flask, dilute with Buffer No. 6 to volume, and mix. Dilute an accurately measured volume of this solution, quantitatively and stepwise, 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.