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Sodium Polystyrene Sulfonate
[C8H7NaxO3S]n Benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt;
 Divinylbenzene copolymer with styrene, sulfonated, sodium salt. [9080-79-9]

BRIEFING

 Sodium Polystyrene Sulfonate. This proposal is based on the version of the monograph official prior to 2013. It is proposed to make the following changes:

  1. Update the chemical information of sodium polystyrene sulfonate.

  2. Add a footnote for the surfactant used in both the test for Sodium Content and the test for Potassium Exchange Capacity.

  3. Provide flexibility in drawing the calibration curve by removing the use of "ruled coordinate paper" in both the test for Sodium Content and the test for Potassium Exchange Capacity.

  4. Provide clarity in preparation of the Standard solutions, Sample stock solution, and Sample solution in the test for Sodium Content.

  5. Correct the analysis equation in the test for Sodium Content.

  6. Provide clarity in preparation of the Standard solutions in the test for Potassium Exchange Capacity.

  7. Correct the analysis equation in the test for Potassium Exchange Capacity.

  8. Add a temperature requirement based on approved product inserts in the Packaging and Storage section.

 Manufacturers are encouraged to submit their methods and FDA-approved specifications for the expert committee's consideration.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 The comment period for this revision ends on July 31, 2025. In the absence of any significant adverse comment, it is proposed to implement this revision via an Interim Revision Announcement with an official date of November 1, 2025.

 (SM4: Y. Yang)

 Case ID—SUB-1492

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