Piperazine Citrate
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(C4H10N2)3·2C6H8O7·xH2O(anhydrous) 642.65

Piperazine,2-hydroxy-1,2,3-propanetricarboxylate (3:2),hydrate.
Piperazine citrate (3:2)hydrate [41372-10-5].

Anhydrous 642.66 [144-29-6].
»Piperazine Citrate contains not less than 98.0percent and not more than 100.5percent of (C4H10N2)3·2C6H8O7,calculated on the anhydrous basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: Dissolve about 200mg in 5mLof 3Nhydrochloric acid,and add,with stirring,1mLof sodium nitrite solution (1in 2).Chill in an ice bath for 15minutes,stirring if necessary,to induce crystallization,filter the precipitate on a sintered-glass funnel,wash with 10mLof cold water,and dry at 105:the N,N¢-dinitrosopiperazine so obtained melts between 156and 160.
B: It responds to the tests for Citrate á191ñ.
Water,Method Iá921ñ: not more than 12.0%.
Primary amines and ammonia— Dissolve 500mg in 10mLof water.Add 1mLof 2.5Nsodium hydroxide,1mLof acetone,and 1mLof sodium nitroferricyanide TS.Mix,and allow to stand for 10minutes,accurately timed.Determine the absorbance of this solution at 520nm and at 600nm,using a blank consisting of the same quantities of the same reagents,but substituting water for the sodium hydroxide solution.The ratio A600/A520is not more than 0.50(equivalent to about 0.7%of primary amines and ammonia).
Assay— Dissolve about 200mg of Piperazine Citrate,accurately weighed,in 100mLof glacial acetic acid TS,warming slightly if necessary to effect solution.Add crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 10.71mg of (C4H10N2)3·2C6H8O7.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1568
Phone Number:1-301-816-8178