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ESR dosimetry of irradiated ascorbic acid

J P Basly1, I Longy, M Bernard

  • 1Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Limoges, France. Basly@alpha1.unilim.fr

Pharmaceutical Research
|November 5, 1997
PubMed
Summary

Electron Spin Resonance (ESR) can quantify gamma irradiation doses in ascorbic acid, distinguishing treated products even after 800 days. This method offers a sensitive, non-destructive alternative for pharmaceutical sterilization verification.

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Radiation Chemistry

Background:

  • Ionizing radiation is an emerging sterilization method for medicinal products, offering an alternative to heat and gas exposure.
  • Electron Spin Resonance (ESR) spectroscopy is being explored for its potential in verifying sterilization processes.

Purpose of the Study:

  • To develop mathematical models describing Electron Spin Resonance (ESR) signal changes in ascorbic acid after gamma irradiation.
  • To correlate ESR signal intensity with radiation dose and storage duration.

Main Methods:

  • Utilized existing ESR data sets of gamma-irradiated ascorbic acid.
  • Developed and tested various mathematical models including linear regression, quadratic fit, power function, exponential function, and bi-exponential functions.

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  • Analyzed radical decay kinetics over time.

    • Main Results:

    • Established a limit of detection of 0.5 kGy and a limit of discrimination of 2 kGy for irradiated ascorbic acid.
    • Linear regression is effective for doses below 25 kGy, while more complex models (bi-exponential) are suitable for broader applications.
    • Distinguishing between irradiated and unirradiated samples is feasible after 800 days of storage.

    Conclusions:

    • ESR spectroscopy is currently the only validated technique for identifying and quantifying irradiated pharmaceuticals.
    • ESR offers advantages in sensitivity, precision, ease of use, and non-destructive analysis compared to other methods.