Piperazine Citrate Tablets
» Piperazine Citrate Tablets contain an amount of piperazine citrate equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of piperazine hexahydrate (C4H10N2·6H2O).
Packaging and storage Preserve in tight containers.
A: Finely powder a number of Tablets, equivalent to about 200 mg of piperazine citrate, mix with 5 mL of 3 N hydrochloric acid, and filter. To the filtrate add, with stirring, 1 mL of sodium nitrite solution (1 in 2). Chill in an ice bath for 15 minutes, stirring if necessary, to induce crystallization, filter the precipitate on a sintered-glass funnel, wash with 10 mL of cold water, and dry at 105: the N,N¢-dinitrosopiperazine so obtained melts between 156 and 160.
B: To a quantity of powdered Tablets, equivalent to about 500 mg of piperazine citrate, add 10 mL of water, shake, and filter: the filtrate responds to the tests for Citrate 191.
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
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 C4H10N2·6H2O is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay Weigh and finely powder not less than 20 Tablets. Shake an accurately weighed portion of the powder, equivalent to about 200 mg of piperazine citrate, for 1 hour with 10 mL of a mixture of 1 part of 3 N hydrochloric acid and 3 parts of water, filter, and wash the residue with two 10-mL portions of water. To the combined extract and washings add 75 mL of trinitrophenol TS, and proceed as directed in the Assay under Piperazine Citrate Syrup, beginning with stir well.
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USP32NF27 Page 3315Pharmacopeial Forum: Volume No. 30(1) Page 165