caa a22 4500 477126243 CHVBK 20180405111650.0 cr unu---uuuuu 170330e19970901xx s 000 0 eng 10.1023/A:1012102806800 doi (NATIONALLICENCE)springer-10.1023/A:1012102806800 ESR Dosimetry of Irradiated Ascorbic Acid [Elektronische Daten] [J.P. Basly, I. Longy, M. Bernard] Purpose. As an alternative to heat and gas exposure sterilization, ionizing radiation is gaining interest as a sterilization process for medicinal products. The aim of this work was to develop equations to describe the ESR curves versus dose and storage time after gamma irradiation of ascorbic acid. Several ESR data sets previously acquired in this laboratory were adopted to check the performance of the models. Results. Limit of detection and limit of discrimination are respectively 0.5 kGy and 2 kGy for ascorbic acid. Linear regression is applicable for doses lower than 25 kGy. Since the radiation dose selected must always be based upon the bioburden of the products and the Degree of Sterility required (ANSI/AAMI/ISO 11137), doses in the range 5−25 kGy could be investigated and linear regression would appear to be the least expensive route to follow and gives good results. Quadratic fit, power function, exponential function and bi-exponential functions are of more general applicability to predict irradiation dose. Decay kinetics for radicals versus storage were considered. Nonhomogeneous kinetics with time-dependent rate (diffusion-controlled second-order reaction) and bi-exponential function appeared valid to reproduce the experimental data. Discrimination between irradiated and unirradiated ascorbic acid is possible after a storage of 800 days. Conclusions. It is worth noting that, at present, ESR is the only technique which proves to be suitable for identification and quantification purposes in irradiated pharmaceuticals. Moreover, other features such as sensitivity, precision, ease and non-destructive readout make ESR superior to other proposed analytical techniques. Plenum Publishing Corporation, 1997 radiosterilization nationallicence ascorbic acid nationallicence ESR nationallicence dosimetry nationallicence decay of radicals nationallicence Basly J.P. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Longy I. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Bernard M. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/9(1997-09-01), 1186-1191 0724-8741 14:9<1186 1997 14 11095 https://doi.org/10.1023/A:1012102806800 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1023/A:1012102806800 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Basly J.P. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 700 1- Longy I. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 700 1- Bernard M. Laboratoire de Chimie Analytique et Bromatologie, UFR de Pharmacie, 2 rue du docteur Marcland, 87025, Limoges Cedex, France aut NATIONALLICENCE 773 0- Pharmaceutical Research Kluwer Academic Publishers-Plenum Publishers 14/9(1997-09-01), 1186-1191 0724-8741 14:9<1186 1997 14 11095 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer