Amphotericin Bfor Injection
»Amphotericin Bfor Injection is a sterile complex of Amphotericin Band deoxycholate sodium and one or more suitable buffers.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of C47H73NO17.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,in a refrigerator and protected from light.
Labeling— Label it to indicate that it is intended for use by intravenous infusion to hospitalized patients only,and that the solution should be protected from light during administration.
Bacterial endotoxins á85ñ— It contains not more than 5.0USP Endotoxin Units per mg of amphotericin B.For products used or labeled for intrathecal injection,it contains not more than 0.9USP Endotoxin Unit per mg of amphotericin B.
Sterility á71ñ— It meets the requirements when tested as directed in the section Membrane Filtrationunder Test for Sterility of the Product to be Examined,50mg from each container being tested.
pHá791ñ: between 7.2and 8.0,in an aqueous solution containing 10mg of amphotericin Bper mL.
Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 8.0%of its weight.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Assay preparation 1 (where it is packaged as a single-dose container)—Constitute Amphotericin Bfor Injection as directed in the labeling.Withdraw all of the withdrawable contents,using a suitable hypodermic needle and syringe,and dilute quantitatively and stepwise with dimethyl sulfoxide to obtain a solution containing about 20µg of amphotericin Bper mL.
Assay preparation 2 (where the labeling states the quantity of amphotericin Bin a given volume of constituted solution)—Constitute Amphotericin Bfor Injection as directed in the labeling.Withdraw an accurately measured volume of the resultant solution,using a suitable hypodermic needle and syringe,and dilute quantitatively and stepwise with dimethyl sulfoxide to obtain a solution containing about 20µg of amphotericin Bper mL.
Procedure— Proceed as directed for amphotericin Bunder Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Assay preparationdiluted quantitatively and stepwise with Buffer No.10to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 150
Phone Number:1-301-816-8335