Amphotericin B for Injection
» Amphotericin B for Injection is a sterile complex of Amphotericin B and deoxycholate sodium and one or more suitable buffers. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C47H73NO17.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, 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 85 It contains not more than 5.0 USP Endotoxin Units per mg of amphotericin B. For products used or labeled for intrathecal injection, it contains not more than 0.9 USP Endotoxin Unit per mg of amphotericin B.
Sterility 71 It meets the requirements when tested as directed in the section Membrane Filtration under Test for Sterility of the Product to be Examined, 50 mg from each container being tested.
pH 791: between 7.2 and 8.0, in an aqueous solution containing 10 mg of amphotericin B per mL.
Loss on drying 731 Dry about 100 mg in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 8.0% of its weight.
Other requirements— It meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
Assay preparation 1 (where it is packaged as a single-dose container)—Constitute Amphotericin B for 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 20 µg of amphotericin B per mL.
Assay preparation 2 (where the labeling states the quantity of amphotericin B in a given volume of constituted solution)—Constitute Amphotericin B for 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 20 µg of amphotericin B per mL.
Procedure— Proceed as directed for amphotericin B under Antibiotics—Microbial Assays 81, using an accurately measured volume of Assay preparation diluted quantitatively and stepwise with Buffer No. 10 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1548