Aminocaproic Acid Tablets

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 Tablets contain NLT 95.0% and NMT 105.0% 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: Triturate 2 Tablets with 10 mL of water, and filter into 100 mL of acetone. Swirl the mixture, and allow to stand for 15 min to complete crystallization. Pass the solution through a sintered-glass filter of medium pore size, and wash the crystals with 25 mL of acetone. Apply vacuum to remove the solvent, dry at 105° for 30 min, and cool. Use the residue.

Acceptance criteria: Meet the requirements

3 ASSAY

Procedure

Sample solution: Nominally equivalent to about 500 mg of aminocaproic acid from NLT 20 finely powdered Tablets taken in a beaker in about 100 mL of glacial acetic acid. Heat gently to effect solution, and cool.

Titrimetric system

Mode: Direct titration

Titrant: 0.1 N perchloric acid in dioxane VS

Endpoint detection: Visual

Analysis: To the Sample solution add 10 drops of a 1-in-500 solution of crystal violet in chlorobenzene. Titrate with Titrant to a blue endpoint, and perform a blank determination. Each mL of 0.1 N perchloric acid is equivalent to 13.12 mg of aminocaproic acid (C₆H₁₃NO₂).

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

4.1 Dissolution 〈711〉

Test 1

Medium: Water; 900 mL

Apparatus 1: 100 rpm

Time: 45 min

Buffer: Dissolve 6.185 g of boric acid and 7.930 g of potassium chloride in about 1000 mL of water, and add 60 mL of 1.0 N sodium hydroxide. Dilute with water to 2000 mL, and adjust if necessary with 1.0 N sodium hydroxide to a pH of 9.5 ± 0.1. Standard solution: 0.5 mg/mL of USP Aminocaproic Acid RS in water

Sample solution: Filter a portion of the solution under test.

Blank: Water

Analysis: Into three separate 50-mL volumetric asks pipet 1 mL each of Sample solution, Standard solution, and Blank. Add 20.0 mL of Buffer and 3.0 mL of a freshly prepared 1-in-500 solution of β-naphthoquinone-4-sodium sulfonate to each ask. Swirl to mix, and place the three asks in a water bath maintained at a temperature of 65 ± 5° for 45 min. Cool, and dilute the contents of each ask with water to volume.

Determine the percentage of the labeled amount of aminocaproic acid (C₆H₁₃NO₂) dissolved from absorbances, at the wavelength of maximum absorbance at about 460 nm, from the Sample solution in comparison with those from the Standard solution, using the Blank to set the instrument.

Tolerances: NLT 75% (Q) of the labeled amount of aminocaproic acid (C₆H₁₃NO₂) is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N hydrochloric acid; 500 mL

Apparatus 1: 100 rpm

Time: 30 min

Buffer A: Dissolve 500 mg of sodium 1-heptanesulfonate in 1 L of water. Add 1.0 mL of triethylamine and mix well. Buffer B: Dissolve 13.3 g of monobasic sodium phosphate in 1 L of Buffer A, and mix well. Adjust with phosphoric acid to a pH of 2.20 ± 0.05.

[Note—The pH of Buffer B is critical because the diluent peak can coelute with the main peak even when the pH of Buffer B is at 2.10 or 2.30.]

Mobile phase: Methanol and Buffer B (25:75)

Standard solution: 1 mg/mL of USP Aminocaproic Acid RS in Medium. Sonication may be needed to aid the dissolution. Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-μm pore size. Discard the first few milliliters of filtrate.

4.1.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

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

Temperatures

Autosampler: 25°

Column: 50°

Flow rate: 1 mL/min

Injection volume: 25 µL

Run time: NLT 2.5 times the retention time of aminocaproic acid

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.5

Relative standard deviation: NMT 2.0%

4.1.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of aminocaproic acid (C₆H₁₃NO₂) dissolved:

Result = (r_U /r_S) × C_S × V × (1/L) × 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)

V = volume of Medium, 500 mL

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of aminocaproic acid (C₆H₁₃NO₂) is dissolved.

4.2 Uniformity of Dosage Units 〈905〉

Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Aminocaproic Acid RS