Packaging and storage— Preserve in collapsible tubes, or other well-closed containers.

USP Reference standards 11— USP Amphotericin B RS.

Minimum fill 755: meets the requirements.

Residual solvents 467: 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.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 164

Phone Number : 1-301-816-8223