Potassium Citrate and Citric Acid Oral Solution
» Potassium Citrate and Citric Acid Oral Solution is a solution of Potassium Citrate and Citric Acid in a suitable aqueous medium. It contains, in each 100 mL, not less than 7.55 g and not more than 8.35 g of potassium (K), and not less than 12.18 g and not more than 13.46 g of citrate (C6H5O7), equivalent to not less than 20.9 g and not more than 23.1 g of potassium citrate monohydrate (C6H5K3O7·H2O); and not less than 6.34 g and not more than 7.02 g of citric acid monohydrate (C6H8O7·H2O).
noteThe potassium ion content of Potassium Citrate and Citric Acid Oral Solution is approximately 2 mEq per mL.
Packaging and storage Preserve in tight containers.
(Official January 1, 2009)
A: To 2 mL of a dilution of Oral Solution (1 in 40) add 5 mL of sodium cobaltinitrite TS: a yellow precipitate is formed immediately (presence of potassium).
B: To a mixture of 1 mL of Oral Solution with 1 mL of hydrochloric acid add 10 mL of cobalt-uranyl acetate TS, and stir with a glass rod: no precipitate or turbidity forms after 15 minutes, and the solution remains clear (absence of sodium).
C: It responds to the test for Citrate 191, 3 to 5 drops of Oral Solution and 20 mL of the mixture of pyridine and acetic anhydride being used.
pH 791: between 4.9 and 5.4.
Assay for potassium
Potassium stock solution, Sodium stock solution, Lithium diluent solution, and Standard preparation Prepare as directed in the Assay for sodium and potassium under Tricitrates Oral Solution.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 2 g of potassium citrate monohydrate, to a 200-mL volumetric flask, dilute with water to volume, and mix. Transfer 50 µL of this solution to a 10-mL volumetric flask, dilute with Lithium diluent solution to volume, and mix.
Procedure Using a suitable flame photometer, adjusted to read zero with Lithium diluent solution, concomitantly determine the potassium flame emission readings for the Standard preparation and the Assay preparation at the wavelength of maximum emission at about 766 nm. Calculate the quantity, in g, of K in the portion of Oral Solution taken by the formula:
(18.64/12.5)(39.10/74.55)(RU,K / RS,K)in which 18.64 is the weight, in g, of potassium chloride in the Potassium stock solution; 39.10 is the atomic weight of potassium; 74.55 is the molecular weight of potassium chloride; and RU,K and RS,K are the potassium emission readings obtained for the Assay preparation and the Standard preparation, respectively.
Assay for citrate
Cation-exchange column Mix 10 g of styrene-divinylbenzene cation-exchange resin with 50 mL of water in a suitable beaker. Allow the resin to settle, and decant the supernatant until a slurry of resin remains. Pour the slurry into a 15-mm × 30-cm glass chromatographic tube (having a sealed-in, coarse-porosity fritted disk and fitted with a stopcock), and allow to settle as a homogeneous bed. Wash the resin bed with about 100 mL of water, closing the stopcock when the water level is about 2 mm above the resin bed.
Procedure Pipet 15 mL of Oral Solution into a 250-mL volumetric flask, dilute with water to volume, and mix. Pipet 5 mL of this solution carefully onto the top of the resin bed in the Cation-exchange column. Place a 250-mL conical flask below the column, open the stopcock, and allow to flow until the solution has entered the resin bed. Elute the column with 60 mL of water at a flow rate of about 5 mL per minute, collecting about 65 mL of the eluate. Add 5 drops of phenolphthalein TS to the eluate, swirl the flask, and titrate with 0.02 N sodium hydroxide VS. Record the buret reading, and calculate the volume (B) of 0.02 N sodium hydroxide consumed. Each mL of the difference between the volume (B) and the volume (A) of 0.02 N sodium hydroxide consumed in the Assay for citric acid is equivalent to 1.261 mg of C6H5O7.
(Official until January 1, 2009)
Assay for citrate
Mobile Phase, Standard Preparation 1, and Chromatographic System Proceed as directed under Assay for Citric Acid/Citrate and Phosphate 345.
Assay preparation Pipet 15 mL of Oral Solution into a suitable volumetric flask, and proceed as directed for Assay Preparation for Citric Acid/Citrate Assay under Assay for Citric Acid/Citrate and Phosphate 345.
Procedure Proceed as directed for Procedure under 345, and calculate the concentration, in mg per mL, of citrate (C6H5O7) in the Oral Solution taken by the formula:
0.001CS (D / V)(rU / rS) A(189.10 / 210.14)in which CS is the concentration, in µg per mL, of citrate in Standard preparation 1; D is the dilution factor; V is the volume of Oral Solution used in the preparation of the Assay preparation; rU and rS are the citrate peak areas obtained from the Assay preparation and Standard Preparation 1, respectively; 189.10 is the molecular weight of citrate (C6H5O7); 210.14 is the molecular weight of citric acid monohydrate (C6H8O7·H2O); and A is the concentration of citric acid monohydrate, in mg per mL, determined in the Assay for citric acid.
(Official January 1, 2009)
Assay for citric acid Transfer 15 mL of Oral Solution, accurately measured, to a 250-mL volumetric flask, dilute with water to volume, and mix. Pipet 5 mL of this solution into a suitable flask, add 25 mL of water and 5 drops of phenolphthalein TS, and titrate with 0.02 N sodium hydroxide VS to a pink endpoint. Record the buret reading, and calculate the volume (A) of 0.02 N sodium hydroxide consumed. Each mL of 0.02 N sodium hydroxide is equivalent to 1.401 mg of C6H8O7·H2O.
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USP32NF27 Page 3344Pharmacopeial Forum: Volume No. 31(2) Page 444