Aminocaproic Acid Oral Solution

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 Oral Solution contains NLT 95.0% and NMT 115.0% of the labeled amount of aminocaproic acid (C₆H₁₃NO₂).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Mix 1 g of ion-exchange resin (strongly acidic styrene–divinylbenzene cation-exchange resin) with 10 mL of 1 N hydrochloric acid in a 100-mL beaker. Decant and discard the hydrochloric acid, and wash the resin with ve 10-mL portions of water, decanting and discarding the liquid following each washing. Place the washed resin in a 125-mL glass-stoppered, conical ask, and add a volume of Oral Solution, nominally equivalent to 250 mg of aminocaproic acid, and 10 mL of water. Insert the stopper in the ask, and shake by mechanical means for 30 min. Transfer the resin slurry to a sintered-glass funnel of medium pore size. Wash with 100 mL of water, filter by applying suction, and discard the washing. Place a beaker under the stem of the funnel, add 10 mL of 1 N hydrochloric acid to the resin, stir for 4–5 min, and filter by applying suction. Evaporate the filtrate on a steam bath to dryness, dry at 105° for 1 h, and cool.

Acceptance criteria: The residue meets the requirements.

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B. The retention time of the aminocaproic acid peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2022)

3 ASSAY

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Procedure

Solution A: 10 g/L of potassium phosphate, monobasic and 0.55 g/L of sodium 1-heptanesulfonate in water. Adjust with sodium hydroxide to a pH of 6.8.

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Standard solution: 0.5 mg/mL of USP Aminocaproic Acid RS in water

Sample solution: Nominally 0.5 mg/mL of aminocaproic acid from Oral Solution in water

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Column temperature: 40°

Flow rate: 0.7 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.0%

3.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of aminocaproic acid (C₆H₁₃NO₂) in the portion of Oral Solution taken: 

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

r_U = peak response of aminocaproic acid from the Sample solution

r_S = peak response of aminocaproic acid 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) (USP 1-Aug-2022)

Acceptance criteria: 95.0%–115.0%

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4 PERFORMANCE TESTS

Deliverable Volume 〈698〉: Meets the requirements (USP 1-Aug-2022)

5 SPECIFIC TESTS

pH 〈791〉: 6.0–6.5

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Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count is NMT 10² cfu/mL. The total yeasts and molds count is NMT 10¹ cfu/mL. It meets the requirements of the test for absence of Escherichia coli. (USP 1-Aug-2022)

6 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Preserve in tight containers. Store at controlled room temperature. (USP 1-Aug-2022)

USP Reference Standards 〈11〉

USP Aminocaproic Acid RS