Amikacin Sulfate 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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1 DEFINITION

Amikacin Sulfate Injection is a sterile solution of Amikacin Sulfate in Water for Injection, or of Amikacin in Water for Injection prepared with the aid of Sulfuric Acid. It contains NLT 90.0% and NMT 120.0% of the labeled amount of amikacin (C₂₂H₄₃N₅O₁₃).

2 IDENTIFICATION

A. The retention time of the peak for amikacin of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

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3.1 Procedure

Mobile phase: 134 mM sodium hydroxide, prepared as follows. Transfer a volume of deionized water to a suitable plastic container, sonicate, degas, and sparge with helium. While stirring, slowly add sodium hydroxide solution of a suitable concentration.

[Note-Prepare fresh daily. The Mobile phase readily absorbs carbon dioxide and produces carbonate that changes the retention time of amikacin. The use of a 50% (w/w), low-carbonate sodium hydroxide solution is recommended.]

System suitability solution: 0.02 mg/mL of USP Amikacin RS and 0.008 mg/mL of USP Kanamycin Sulfate RS in water

Standard solution: 0.02 mg/mL of USP Amikacin RS in water

Sample solution: Nominally 0.02 mg/mL of amikacin, from Injection in water

3.2 Chromatographic system

Mode: LC

Detector: Electrochemical

Detector mode: Integrated amperometric

Electrodes

Working: Gold

Reference: Silver–silver chloride

Detector settings: See Table 1.

Table 1

Column: 4-mm × 25-cm; 7.5-μm packing L47

[Note-A guard column of packing L47 is recommended.]

Flow rate: 0.5 mL/min

Injection volume: 20 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

[Note - The relative retention times for kanamycin and amikacin are 0.8 and 1.0, respectively.]

3.4 Suitability requirements

Resolution: NLT 3 between kanamycin and amikacin, System suitability solution

Tailing factor: NMT 2, Standard solution

Relative standard deviation: NMT 3%, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of USP41 amikacin (C₂₂H₄₃N₅O₁₃) in the portionUSP41 of Injection taken:

Result = (r_u/r_s) × (C_s/C_u) × P × 100

r_u = peak response of amikacin USP41 from the Sample solution

r_s = peak response of amikacin USP41 from the Standard solution

C_s = concentration of USP Amikacin RS in the Standard solution (mg/mL)

C_u = nominal concentration of amikacin in the Sample solution (mg/mL) (ERR 1-Sep-2018)

P = potency of amikacin in USP Amikacin RS (mg/mg)

Acceptance criteria: 90.0%-120.0%

4 SPECIFIC TESTS

pH 〈791〉: 3.5–5.5

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

Bacterial Endotoxins Test 〈85〉: NMT 0.33 USP Endotoxin Units/mg of amikacin

Other Requirements: Meets the requirements under Injections and Implanted Drug Products 〈1〉

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type III glass.

Change to read:

USP Reference Standards 〈11〉

USP Amikacin RS

(CN 1-May-2018)

USP Kanamycin Sulfate RS