Amphotericin B Cream
» Amphotericin B Cream contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of Amphotericin B.
Packaging and storage Preserve in collapsible tubes, or other well-closed containers.
Minimum fill 755: meets the requirements.
Assay Proceed as directed for amphotericin B under AntibioticsMicrobial Assays 81, blending a suitable accurately weighed portion of Cream in a high-speed blender with a sufficient accurately measured volume of dimethyl sulfoxide to give a convenient concentration. Quantitatively dilute an accurately measured volume of this solution with dimethyl sulfoxide to obtain a stock solution having a concentration of about 20 µg of amphotericin B per mL. Quantitatively dilute an accurately measured volume of this stock solution with Buffer No. 10 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 1548