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Compounding of DMSA Radiopharmaceutical Kits During a Shortage.

Wendy Galbraith1, Megan Baumgartner2, Katie Talley3

  • 1University of Oklahoma Health Campus, College of Pharmacy, Pharmaceutical Sciences, Oklahoma City, Oklahoma. Wendy-galbraith@ouhsc.edu.

International Journal of Pharmaceutical Compounding
|December 16, 2025
PubMed
Summary

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This summary is machine-generated.

A validated method ensures accurate succimer (meso-2,3-dimercaptosuccinic acid, DMSA) content in compounded kits, crucial for diagnosing renal scarring after manufacturing disruptions. The DMSA kits demonstrated stability for 45 days when stored frozen.

Area of Science:

  • Nuclear Pharmacy
  • Radiopharmaceutical Compounding
  • Analytical Chemistry

Background:

  • Commercial manufacturing of succimer (meso-2,3-dimercaptosuccinic acid, DMSA) was halted for 5.5 years (2016-2022).
  • DMSA is essential for diagnosing and staging renal scarring at our academic health center.
  • A reliable method for verifying DMSA content in compounded kits is needed.

Purpose of the Study:

  • To validate a simplified method for verifying the DMSA content in cold reaction vials (kits) after nuclear pharmacy compounding.
  • To ensure the quality and accuracy of DMSA kits post-discontinuation of commercial manufacturing.

Main Methods:

  • A simplified DMSA kit compounding process involved filtering a saturated DMSA solution.
  • Ellman's Reagent (5,5'-dithio-bis-(2-nitrobenzoic acid)) was used to quantify DMSA content via absorbance at 412 nm.

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  • DMSA content was verified over 45 days for frozen kits using a calibration curve.

    • Main Results:

    • All compounded DMSA kits met the USP monograph acceptance criteria for technetium 99m succimer.
    • Statistical analysis confirmed a 95% confidence interval within ±10% of labeled DMSA content.
    • The DMSA kits exhibited stability for up to 45 days when stored frozen.

    Conclusions:

    • The validated method provides accurate verification of DMSA content in compounded kits.
    • This method ensures the availability of quality DMSA radiopharmaceuticals for renal scarring diagnosis.
    • Compounded DMSA kits are stable for at least 45 days under frozen conditions.