Aminocaproic Acid Injection
»Aminocaproic Acid Injection is a sterile solution of Aminocaproic Acid in Water for Injection.It contains not less than 95.0percent and not more than 107.5percent of the labeled amount of aminocaproic acid (C6H13NO2).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification— Mix 2mLof Injection,added dropwise,with 100mLof acetone,rapidly stirring the mixture with a glass rod to induce crystallization.Allow the mixture to stand for 15minutes,and pass through a medium-porosity,sintered-glass filter.Wash the crystals with 25mLof acetone,apply vacuum to remove the solvent,dry at 105for 30minutes,and cool:the residue so obtained responds to the Identificationtest under Aminocaproic Acid.
Bacterial endotoxins á85ñ— It contains not more than 0.05USP Endotoxin Unit per mg of aminocaproic acid.
pHá791ñ: between 6.0and 7.6.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase— Transfer 11g of sodium 1-pentanesulfonate and 40g of anhydrous sodium sulfate to a 2-Lvolumetric flask,and dissolve in about 500mLof water.Add 20mLof 1Nsulfuric acid and 30mLof acetonitrile,dilute with water to volume,and mix.Filter and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Aminocaproic Acid RSin Mobile phaseto obtain a solution having a known concentration of about 2.5mg per mL.
Resolution solution— Mix 20µLof benzyl alcohol with 100mLof water.Dilute 1.0mLof this solution with the Standard preparationto 10mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 1.25g of aminocaproic acid,to a 50-mLvolumetric flask,dilute with water to volume,and mix.Transfer 5.0mLof the resulting solution to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Chromatographic system(see Chromatography á621ñ)— The liquid chromatograph is equipped with a 210-nm detector and a 4-mm ×30-cm column that contains packing L1.The flow rate is about 2mLper minute.Chromatograph the Resolution solutionas directed for Procedure:the resolution,R,between benzyl alcohol and aminocaproic acid is not less than 7.0.The aminocaproic acid peak elutes prior to the benzyl alcohol peak.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the relative standard deviation for replicate injections is not more than 1.0%.
Procedure— Separately inject equal volumes (about 50µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity,in mg,of aminocaproic acid (C6H13NO2)in each mLof the Injection taken by the formula:
500(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Aminocaproic Acid RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and rUand rSare the aminocaproic acid peak areas obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 123
Phone Number:1-301-816-8305