Amphotericin B for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Amphotericin B for Injection

(This monograph has been updated to the current USP style. No revisions or changes to tests have been made.)

1 DEFINITION

Amphotericin B for Injection is a sterile complex of amphotericin B, deoxycholate sodium, and one or more suitable buffers. It contains NLT 90.0% and NMT 120.0% of the labeled amount of amphotericin B (C₄₇H₇₃NO₁₇).

2 ASSAY

Procedure

Standard: USP Amphotericin B RS

Sample solution 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/mL of amphotericin B.

Sample solution 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/mL of amphotericin B.

Analysis:

Proceed as directed for amphotericin B in Antibiotics—Microbial Assays 〈81〉, using an accurately measured volume of the Sample solution diluted quantitatively and stepwise with Buffer B.10 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.

Acceptance criteria: 90.0%–120.0%

3 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉: Meets the requirements

4 SPECIFIC TESTS

Sterility Tests 〈71〉:

It meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration, 50 mg from each container being tested.

pH 〈791〉

Sample solution: 10 mg/mL of amphotericin B in water

Acceptance criteria: 7.2–8.0

Loss on Drying 〈731〉

Sample: About 100 mg

Analysis: Dry the Sample in a capillary-stoppered bottle in a vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 h.

Acceptance criteria: NMT 8.0%

Other Requirements:

It meets the requirements for Labeling 〈7〉, Labels and Labeling for Injectable Products.

Bacterial Endotoxins Test 〈85〉:

It contains NMT 5.0 USP Endotoxin Units/mg of amphotericin B. For products used or labeled for intrathecal injection, it contains NMT 0.9 USP Endotoxin Units/mg of amphotericin B.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage:

Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for Constitution, 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.

USP Reference Standards 〈11〉

USP Amphotericin B RS