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Sodium Polystyrene Sulfonate Suspension
» Sodium Polystyrene Sulfonate Suspension is a suspension of Sodium Polystyrene Sulfonate in an aqueous vehicle containing a suitable quantity of sorbitol. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sorbitol (C6H14O6), and exchanges not less than 110 mg and not more than 135 mg of potassium for each g of the labeled amount of sodium polystyrene sulfonate.
Packaging and storage— Preserve in well-closed containers, protected from freezing and from excessive heat.
Labeling— Label it to state the quantity of sorbitol in a given volume of Suspension.
Microbial limits 61 Its total aerobic microbial count does not exceed 100 cfu per mL, its total combined molds and yeasts count does not exceed 100 cfu per mL, and it meets the requirements of the test for absence of Pseudomonas aeruginosa.
Sodium content—
Sodium solution and Standard graph— Prepare as directed in the test for Sodium content under Sodium Polystyrene Sulfonate.
Procedure— Transfer an accurately measured quantity of Suspension, freshly mixed and free from air bubbles, equivalent to about 1 g of sodium polystyrene sulfonate, to a suitable crucible, heat at 80 until dry, and ash the residue with a slight excess of sulfuric acid. Proceed as directed for Procedure in the test for Sodium content under Sodium Polystyrene Sulfonate, beginning with “Add 1 mL of nitric acid.” Calculate the percentage of sodium taken by the formula:
A / L,
in which A is the quantity, in mg, of sodium found per liter, and L is the quantity, in g, of sodium polystyrene sulfonate in the portion of Suspension taken, based on the labeled amount: the sodium content is not less than 9.4% and not more than 11.5%.
Potassium exchange capacity—
Potassium solution, Sodium solution, and Standard graph— Prepare as directed in the test for Potassium exchange capacity under Sodium Polystyrene Sulfonate.
Procedure— Transfer an accurately measured quantity of Suspension, freshly mixed and free from air bubbles, equivalent to about 1.6 g of sodium polystyrene sulfonate, to a suitable glass-stoppered flask, add 100.0 mL of Potassium solution, shake by mechanical means for 15 minutes, filter, and discard the first 20 mL of the filtrate. Proceed as directed for Procedure in the test for Potassium exchange capacity under Sodium Polystyrene Sulfonate, beginning with “Pipet 5 mL of the filtrate.” Calculate the quantity, in mg, of potassium adsorbed on each g of the sodium polystyrene sulfonate taken by the formula:
(X 20Y) / L,
in which X is the quantity, in mg, of potassium in 100 mL of Potassium solution before exchange; Y is the quantity, in mg, of potassium per L as interpolated from the Standard graph; and L is the labeled quantity, in g, of sodium polystyrene sulfonate in the portion of Suspension taken.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for sorbitol—
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Sorbitol (see NF monograph).
Assay preparation— Dilute an accurately measured volume of Suspension, freshly mixed and free from air bubbles, quantitatively with water to obtain a solution containing about 4.8 mg of sorbitol per mL. Filter, and use the filtrate as the Assay preparation.
Procedure— Separately inject equal volumes (about 20 µL) of the Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Proceed as directed for Procedure in the Assay under Sorbitol (see NF monograph). Calculate the quantity, in g, of C6H14O6, in each mL of the Suspension taken by the formula:
(L / D)(C)(rU / rS),
in which L is the labeled quantity, in g, of sorbitol in each mL of Suspension; D is the quantity, in mg, of sorbitol in each mL of the Assay preparation based on the labeled quantity and the extent of dilution; C is the concentration, in mg per mL, of USP Sorbitol RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 1990
Pharmacopeial Forum : Volume No. 31(4) Page 1115
Phone Number : 1-301-816-8305