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.
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.
