Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Amphotericin B RS.

Minimum fill á755ñ: meets the requirements.

pHá791ñ: between 5.0and 7.0.

Assay— Proceed as directed for amphotericin Bunder Antibiotics—Microbial Assays á81ñ,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 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 151

Phone Number:1-301-816-8335