Amphotericin B Lotion
» Amphotericin B Lotion 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 well-closed containers.
Minimum fill 755:
meets the requirements.
pH 791:
between 5.0 and 7.0.
Assay
Proceed as directed for amphotericin B under AntibioticsMicrobial Assays 81, quantitatively dissolving a suitable accurately measured volume of Lotion in sufficient 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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1548
Pharmacopeial Forum: Volume No. 30(2) Page 445
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