caa a22 4500 477125832 CHVBK 20180405111649.0 cr unu---uuuuu 170330e19970601xx s 000 0 eng 10.1023/A:1012119026422 doi (NATIONALLICENCE)springer-10.1023/A:1012119026422 Radiation Sterilization of Formoterol [Elektronische Daten] [J. Basly, I. Longy, M. Bernard] 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. Plenum Publishing Corporation, 1997 formoterol nationallicence radiation treatment nationallicence ESR spectroscopy nationallicence dosimetry nationallicence storage nationallicence HPLC nationallicence degradation nationallicence Basly J. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Longy I. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Bernard M. Laboratoire de Biophysique Pharmaceutique, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/6(1997-06-01), 810-814 0724-8741 14:6<810 1997 14 11095 https://doi.org/10.1023/A:1012119026422 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1012119026422 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Basly J. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 700 1- Longy I. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 700 1- Bernard M. Laboratoire de Biophysique Pharmaceutique, UFR de Pharmacie, Université de Limoges, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 773 0- Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/6(1997-06-01), 810-814 0724-8741 14:6<810 1997 14 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer