Kanamycin 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

Kanamycin Injection contains an amount of kanamycin sulfate equivalent to NLT 90.0% and NMT 115.0% of the labeled amount of kanamycin (C₁₈H₃₆N₄O₁₁). It contains suitable buffers and preservatives.

2 IDENTIFICATION

A. Thin-Layer Chromatographic Identification Test 〈201〉

Sample solution: 1 mg/mL of kanamycin from Injection in water

Chromatographic system

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture, heated at 110° for 1 h and cooled immediately before use

Application volume: 10 μL

Developing solvent system: 150 mg/mL of monobasic potassium phosphate in water

Spray reagent: 10 mg/mL of ninhydrin in butyl alcohol

Analysis: Proceed as directed in the chapter. Allow the spots to dry, and develop in a chamber previously equilibrated for 18 h with the

Developing solvent system. Remove the plate from the chamber, and air-dry. Spray the plate with Spray reagent, and dry at 110° for 10 min.

Acceptance criteria: Meets the requirements

B. The retention time of the kanamycin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Mobile phase: 0.115 N sodium hydroxide solution

System suitability solution: 20 μg/mL of USP Amikacin RS and 8 μg/mL of USP Kanamycin Sulfate RS in water

Standard solution: 8 μg/mL of USP Kanamycin Sulfate RS in water

Sample solution: Nominally 6 μg/mL of kanamycin from Injection in water

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Electrochemical

Mode: Integrated amperometric

Range: 300 nC

Output: 1 V full-scale

Electrodes

Indicator: Gold

Reference: pH silver–silver chloride

Waveform: See Table 1.

Table 1

Columns

Guard: Packing L47

Analytical: 4-mm × 25-cm; packing L47

Flow rate: 0.5 mL/min

Injection volume: 20 μL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for kanamycin and amikacin are about 1.0 and 1.3, respectively.]

Suitability requirements

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

Tailing factor: NMT 2, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of kanamycin (C₁₈H₃₆N₄O₁₁) in the portion of Injection taken:

Result = (r_U/r_S)x(C_S/C_U ) × P × F × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

C_S = concentration of USP Kanamycin Sulfate RS in the Standard solution (μg/mL)

C_U = nominal concentration of kanamycin in the Sample solution (μg/mL)

P = potency of kanamycin in USP Kanamycin Sulfate RS (μg/mg)

F = conversion factor, 0.001 mg/μg

Acceptance criteria: 90.0%–115.0%

4 SPECIFIC TESTS

pH 〈791〉: 3.5–5.0

Bacterial Endotoxins Test 〈85〉: NMT 0.67 USP Endotoxin Unit/mg of kanamycin

Sterility Tests 〈71〉: It meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.

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

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

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

USP Reference Standards 〈11〉

USP Amikacin RS

USP Kanamycin Sulfate RS