Packaging and storage— Preserve in tight containers.

USP Reference standards 11— USP Aminocaproic Acid RS.

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

pH 791: between 6.0 and 6.5.

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Oral Solution, equivalent to about 250 mg of aminocaproic acid, to a 250-mL beaker, add 80 mL of glacial acetic acid, and mix. Add 10 drops of a 1 in 500 solution of crystal violet in chlorobenzene, and titrate with 0.1 N perchloric acid in dioxane VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 13.12 mg of aminocaproic acid. (C6H13NO2)

Expert Committee : (MDCV05) Monograph Development-Cardiovascular

USP29–NF24 Page 135

Phone Number : 1-301-816-8305