Piperazine Citrate Tablets
»Piperazine Citrate Tablets contain 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: Finely powder a number of Tablets,equivalent to about 200mg of piperazine citrate,mix with 5mLof 3Nhydrochloric acid,and filter.To the filtrate 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: To a quantity of powdered Tablets,equivalent to about 500mg of piperazine citrate,add 10mLof water,shake,and filter:the filtrate responds to the tests for Citrate á191ñ.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of piperazine hexahydrate (C4H10N2·6H2O)dissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances— Not less than 75%(Q)of the labeled amount of C4H10N2·6H2Ois dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not less than 20Tablets.Shake an accurately weighed portion of the powder,equivalent to about 200mg of piperazine citrate,for 1hour with 10mLof a mixture of 1part of 3Nhydrochloric acid and 3parts of water,filter,and wash the residue with two 10-mLportions of water.To the combined extract and washings add 75mLof trinitrophenol TS,and proceed as directed in the Assayunder Piperazine Citrate Syrup,beginning with “stir well.”
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1568
Pharmacopeial Forum:Volume No.30(1)Page 165
Phone Number:1-301-816-8394