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Radiation-induced effects on cefotaxime: ESR study

J P Basly1, I Basly, M Bernard

  • 1UPRES EA 1085, Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Limoges, France. basly@alpha1.unilim.fr

Free Radical Research
|September 11, 1998
PubMed
Summary

Electron spin resonance (ESR) spectrometry can detect irradiated pharmaceuticals like cefotaxime by identifying free radicals. This method allows for both qualitative detection and quantitative dose estimation, even after two years of storage.

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Radiation Chemistry

Background:

  • Ionizing radiation is an emerging sterilization method for pharmaceuticals, necessitating reliable detection of irradiated products.
  • Current methods for distinguishing irradiated from non-irradiated pharmaceuticals are insufficient, posing a challenge for regulatory agencies.
  • Cefotaxime, a thermosensitive antibiotic, is a suitable model for studying radiation sterilization effects.

Purpose of the Study:

  • To investigate the utility of electron spin resonance (ESR) spectrometry for detecting and quantifying radiosterilized pharmaceuticals.
  • To establish a method for differentiating between irradiated and non-irradiated cefotaxime using ESR.
  • To assess the feasibility of ESR for estimating radiation doses and long-term stability of free radicals in irradiated cefotaxime.

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Main Methods:

  • Electron spin resonance (ESR) spectrometry was employed to analyze irradiated and non-irradiated cefotaxime samples.
  • Free radical concentration was quantified by comparing ESR signal integrals to a diphenyl-picrylhydrazyl (DPPH) reference standard.
  • Dose-response relationships were analyzed using various mathematical functions (linear, quadratic, exponential, bi-exponential).

Main Results:

  • Non-irradiated cefotaxime exhibited no ESR signal, while irradiated samples showed a dose-dependent signal attributed to free radicals.
  • The concentration of free radicals was determined to be 1.9 x 10^20 radicals mol⁻¹ at 20 kGy, yielding a G-value of 0.3.
  • ESR peak-to-peak amplitude correlated well with radiation dose, particularly with linear regression for doses below 20 kGy.
  • Detected free radicals remained stable for at least 57 days, enabling detection of radiosterilized cefotaxime up to two years post-irradiation.

Conclusions:

  • ESR spectrometry is a viable technique for the qualitative detection of radiosterilized cefotaxime.
  • ESR can be used for radiation dosimetry, with linear correlation suitable for lower doses (below 20 kGy).
  • The stability of induced free radicals allows for long-term identification of irradiated pharmaceuticals, supporting regulatory compliance.