Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Antihelminthic.
DEFINITION
Piperazine Citrate Tablets contain Piperazine Citrate.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of anhydrous piperazine citrate, (C4H10N2)3,2C6H8O7
81.6 to 96.8% of the stated amount of Piperazine Citrate.
IDENTIFICATION
Extract a quantity of the powdered tablets containing 1 g of Piperazine Citrate with 20 mL of water and filter. The filtrate complies with the following tests.
A. Dilute 1 mL to 5 mL with water, add 0.5 g of sodium hydrogen carbonate, 0.5 mL of potassium hexacyanoferrate(III) solution and 0.1 mL of mercury, shake vigorously for 1 minute and allow to stand for 20 minutes; a reddish colour slowly develops.
B. Mix 4 mL with 1 mL of hydrochloric acid, add 0.5 g of sodium nitrite, heat to boiling, cool in ice for 15 minutes, scratching the side of the container with a glass rod to induce crystallisation and filter. The melting point of the crystals, after washing with 10 mL of iced water and drying at 100° to 105°, is about 159°, Appendix V A, Method I.
C. Yield the reactions characteristic of citrates, Appendix VI.
ASSAY
Weigh and powder 20 tablets. Dissolve as completely as possible a quantity of the powder containing 0.2 g of Piperazine Citrate in 10 mL of water, filter and wash the filter with three 5 mL quantities of water. To the combined filtrate and washings add 3.5 mL of 0.5M sulfuric acid and 100 mL of picric acid solution R1, heat on a water bath for 15 minutes, allow to stand for 1 hour, filter, wash the residue with piperazine dipicrate solution until the washings are free from sulfate and dry the residue to constant weight at 105°. Each g of residue is equivalent to 0.3935 g of (C4H10N2)3,2C6H8O7.
STORAGE
Piperazine Citrate Tablets should be protected from light.
