Aminocaproic Acid

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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C₆H₁₃NO₂ 131.17

Hexanoic acid, 6-amino-;

6-Aminohexanoic acid CAS RN^®: 60-32-2; UNII: U6F3787206.

1 DEFINITION

Aminocaproic Acid contains NLT 98.5% and NMT 101.5% of aminocaproic acid (C₆H₁₃NO₂), calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

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

3 ASSAY

Procedure

Solution A: 0.55 g/L of sodium 1-heptanesulfonate in water

Mobile phase: Dissolve 10 g of monobasic potassium phosphate in 300 mL of Solution A, and add 250 mL of methanol, followed by another 300 mL of Solution A. Adjust the mixture with phosphoric acid to a pH of 2.2, and dilute with Solution A to 1 L. Internal standard solution: 1.25 mg/mL of Methionine in water

Standard stock solution: 12.5 mg/mL of USP Aminocaproic Acid RS in water

Standard solution: 5.0 mL of Standard stock solution and 2.0 mL of Internal standard solution in a 100-mL volumetric flask. Dilute with water to volume.

Sample stock solution: 12.5 mg/mL of Aminocaproic Acid in water

Sample solution: 5.0 mL of Sample stock solution and 2.0 mL of Internal standard solution in a 100-mL volumetric flask. Dilute with water to volume.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 15-cm; packing L1

Column temperature: 30°

Flow rate: 0.7 mL/min

Run time: NLT 2 times the retention time of aminocaproic acid

Injection volume: 20 µL

System suitability

Sample: Standard solution

[Note—The relative retention times for aminocaproic acid and methionine are about 0.76 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between aminocaproic acid and methionine

Relative standard deviation: NMT 2.0%

3.2 Analysis

Samples: Standard solution and Sample solution

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

Result = (R_U /R_S ) × (C_S /C_U) × 100

R_U = peak response ratio of aminocaproic acid to the internal standard from the Sample solution

R_S = peak response ratio of aminocaproic acid to the internal standard from the Standard solution

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

C_U = concentration of Aminocaproic Acid in the Sample solution (mg/mL)

Acceptance criteria: 98.5%–101.5% on the anhydrous basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

5 SPECIFIC TESTS

Water Determination, Method I〈921〉: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers. Store at room temperature.

USP Reference Standards 〈11〉

USP Aminocaproic Acid RS.