Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Amphotericin B RS.

Minimum fill 755: meets the requirements.

pH 791: between 5.0 and 7.0.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 165

Phone Number : 1-301-816-8223