Aminocaproic Acid Tablets, chemical structure, molecular formula, Reference Standards

Aminocaproic Acid Tablets

»Aminocaproic Acid Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of aminocaproic acid (C6H13NO2).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Aminocaproic Acid RS.

Identification— Triturate 2Tablets with 10mLof water,and filter into 100mLof acetone.Swirl the mixture,and allow to stand for 15minutes to complete crystallization.Filter through a medium-porosity,sintered-glass filter,and wash the crystals with 25mLof acetone.Apply vacuum to remove the solvent,then dry at 105

for 30minutes,and cool:the residue so obtained responds to the Identificationtest under Aminocaproic Acid.

Dissolution á711ñ—

Medium: water;900mL.

Apparatus 1: 100rpm.

Time: 45minutes.

pH9.5borate buffer— Dissolve 6.185g of boric acid and 7.930g of potassium chloride in about 1000mLof water,add 60mLof 1.0Nsodium hydroxide,and mix.Dilute with water to 2000mL,mix,and add 1.0Nsodium hydroxide,if necessary,to adjust to a pHof 9.5±0.1.

Standard preparation— Dissolve an accurately weighed quantity of USP Aminocaproic Acid RSin water,and quantitatively dilute with water to obtain a solution having a known concentration of about 0.5mg per mL.

Procedure— Into three separate 50-mLvolumetric flasks pipet (a)1mLof a filtered portion of the solution under test,(b)1mLof the Standard preparation,and (c)1mLof water to provide a blank.Add 20.0mLof pH9.5borate bufferand 3.0mLof freshly prepared b-naphthoquinone-4-sodium sulfonate solution (1in 500)to each,swirl to mix,and place the 3flasks in a water bath maintained at a temperature of 65±5

for 45minutes.Cool,dilute each with water to volume,and mix.Determine the amount of C6H13NO2dissolved from absorbances,at the wavelength of maximum absorbance at about 460nm,obtained from the test solution in comparison with those obtained from the Standard solution,using the blank to set the instrument.

Tolerances— Not less than 75%(Q)of the labeled amount of C6H13NO2is dissolved in 45minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of aminocaproic acid,to a beaker,add about 100mLof glacial acetic acid,heat gently to effect solution,and cool.Add 10drops of a 1in 500solution of crystal violet in chlorobenzene,and titrate with 0.1Nperchloric acid in dioxane VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 13.12mg of aminocaproic acid (C6H13NO2).

Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate

Expert Committee:(PA5)Pharmaceutical Analysis 5

USP28–NF23Page 124

Phone Number:1-301-816-8305