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

USP Reference standards á11ñ— USP Amphotericin B RS.

Minimum fill á755ñ: meets the requirements.

Assay— Proceed as directed for amphotericin Bunder Antibiotics—Microbial Assays á81ñ,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 20µg of amphotericin Bper mL.Quantitatively dilute an accurately measured volume of this stock solution with Buffer No.10to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 150

Phone Number:1-301-816-8335