Piperazine Citrate Syrup
»Piperazine Citrate Syrup is prepared from Piperazine Citrate or from Piperazine to which an equivalent amount of Citric Acid is added.It contains an amount of piperazine citrate equivalent to not less than 93.0percent and not more than 107.0percent of the labeled amount of piperazine hexahydrate (C4H10N2·6H2O).
Packaging and storage—
Preserve in tight containers.
Identification—
A:
To 2mLof Syrup add 5mLof 3Nhydrochloric acid,then 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.
:the N,N¢-dinitrosopiperazine so obtained melts between 156and 160.
B:
It responds to the tests for Citrate á191ñ.
Assay—
Determine the specific gravity of Syrup,and transfer an accurately weighed portion of the Syrup,equivalent to about 200mg of piperazine citrate,to a 250-mLbeaker.Add 10mLof water and 75mLof trinitrophenol TS,stir well,and allow to stand in a refrigerator for not less than 2hours.Collect the precipitate in a tared filtering crucible,wash with five 10-mLportions of dehydrated alcohol,and dry at 105to constant weight.[Caution—Picrates may explode.]The weight of the dipicrate,multiplied by 0.3568,gives the equivalent of C4H10N2·6H2Oin the portion of Syrup taken.
to constant weight.[Caution—Picrates may explode.]The weight of the dipicrate,multiplied by 0.3568,gives the equivalent of C4H10N2·6H2Oin the portion of Syrup taken.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1568
Phone Number:1-301-816-8394