Aminocaproic Acid 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

Aminocaproic Acid Injection is a sterile solution of Aminocaproic Acid in Water for Injection. It contains NLT 95.0% and NMT 107.5% of the labeled amount of aminocaproic acid (C₆H₁₃NO₂).

2 IDENTIFICATION

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A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K _{(CN 1-May-2020)}

Sample: Mix 2 mL of Injection, added dropwise, with 100 mL of acetone, rapidly stirring the mixture with a glass rod to induce crystallization. Allow the mixture to stand for 15 min, and pass through a sintered-glass filter of medium pore size. Wash the crystals with 25 mL of acetone, apply a vacuum to remove the solvent, dry at 105° for 30 min, and cool. Use the residue.

Acceptance criteria: Meets the requirements

3 ASSAY

Procedure

Mobile phase: Transfer 11 g of sodium 1-pentanesulfonate and 40 g of anhydrous sodium sulfate to a 2-L volumetric ask, and dissolve in about 500 mL of water. Add 20 mL of 1 N sulfuric acid and 30 mL of acetonitrile, and dilute with water to volume. Standard solution: 2.5 mg/mL of USP Aminocaproic Acid RS in Mobile phase

System suitability solution: Mix 20 µL of benzyl alcohol with 100 mL of water. Dilute 1.0 mL of this solution with Standard solution to 10 mL. Sample stock solution: Nominally equivalent to 25 mg/mL of aminocaproic acid from a suitable volume of Injection in water Sample solution: 2.5 mg/mL of Sample stock solution in Mobile phase

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4-mm × 30-cm; packing L1

Flow rate: 2 mL/min

Injection volume: 50 µL

System suitability

Samples: Standard solution and System suitability solution

Suitability requirements

Resolution: NLT 7.0 between benzyl alcohol and aminocaproic acid, System suitability solution

[Note—The aminocaproic acid peak elutes before the benzyl alcohol peak.]

Relative standard deviation: NMT 1.0%, Standard solution

3.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of aminocaproic acid (C₆H₁₃NO₂) in the portion of Injection taken:

Result = (r_U /r_S ) × (C_S /C_U ) × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

C_S = concentration of USP Aminocaproic Acid RS in the Standard solution (mg/mL)

C_U = nominal concentration of aminocaproic acid in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–107.5%

4 SPECIFIC TESTS

pH 〈791〉: 6.0–7.6

Bacterial Endotoxins Test 〈85〉 : NMT 0.05 USP Endotoxin Unit/mg of aminocaproic acid

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 glass.

USP Reference Standards 〈11〉

USP Aminocaproic Acid RS