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 Antibiotics—Microbial 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.
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