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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    Pharmaceutical research 14 (1997), S. 810-814 
    ISSN: 1573-904X
    Keywords: formoterol ; radiation treatment ; ESR spectroscopy ; dosimetry ; storage ; HPLC ; degradation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Purpose. Radiation sterilization is becoming increasingly popular for the sterilization of many pharmaceutical products. We have investigated the gamma radiation induced effects on formoterol fumarate by HPLC and ESR spectroscopy. Results and Discussion. Numerical simulation of the evolution of the ESR signal versus dose was performed using linear regression, quadratic fit and power function. The shape of the dosimetric curve is linear in the range 5−30 kGy. Owing to the weak number of free radicals generated during the irradiation, the accuracy of measurements is low. For a dose of 25 kGy, discriminating irradiated from unirradiated samples is possible if the storage period is less than 250 days. The comparison between chromatographic profiles of irradiated and unirradiated samples showed minor differences. Conclusions. From our preliminary results, radiosterilization of formoterol fumarate may be technically feasible. Estimation of the irradiation dose by ESR may be possible but, due to the weak number of free radicals generated during the irradiation, the accuracy of measurements appeared low.
    Type of Medium: Electronic Resource
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