Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Aminocaproic Acid RS.

Identification— Mix about 1g of ion-exchange resin (strongly acidic styrene-divinylbenzene cation-exchange resin)with about 10mLof 1Nhydrochloric acid in a 100-mLbeaker.Decant and discard the hydrochloric acid,and wash the resin with five 10-mLportions of water,decanting and discarding the liquid following each washing.Place the washed resin in a glass-stoppered,125-mLconical flask,and add a volume of Oral Solution,equivalent to about 250mg of aminocaproic acid,and 10mLof water.Insert the stopper in the flask,and shake by mechanical means for 30minutes.Transfer the resin slurry to a medium-porosity,sintered-glass funnel,wash with about 100mLof water,apply suction to filter,and discard the washing.Place a 100-mLbeaker under the stem of the funnel,add 10mLof 1Nhydrochloric acid to the resin,stir for 4to 5minutes,and filter by applying suction.Evaporate the filtrate on a steam bath to dryness,dry at 105for 1hour,and cool:the residue so obtained meets the requirements for the Identificationtest under Aminocaproic Acid.

pHá791ñ: between 6.0and 6.5.

Assay— Transfer an accurately measured volume of Oral Solution,equivalent to about 250mg of aminocaproic acid,to a 250-mLbeaker,add 80mLof glacial acetic acid,and mix.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)

(Official June 1,2005)

Expert Committee:(PA5)Pharmaceutical Analysis 5

USP28–NF23Page 124

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