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 Antibiotics—Microbial 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.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1548
Pharmacopeial Forum: Volume No. 30(2) Page 445