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Radiation sterilization of ketoprofen

Abstract

Radiation sterilization of ketoprofen (KP) dry powder was investigated by selected physico-chemical methods. High-performance liquid chromatography, ultraviolet spectrophotometry, infrared spectrophotometry, differential scanning calorimetry, X-ray diffraction and electron spin resonance spectroscopy did not show any significant degradation at sterilization dose 25 kGy. To determine the nature, extent and direction of radiation-induced changes, KP was irradiated to extremely high doses, much higher than necessary to achieve sterility. The irradiated KP did not show any difference of XRD patterns up to 200 kGy; with DSC and IR some changes were detected only above 1000 and 2000 kGy, respectively; HPLC has shown about 5% destruction at 2000 kGy. Acetyl benzophenon (AcBph) was generated by irradiation with G(AcBph)=(1.6{+-}0.1)x10{sup -8} mol J{sup -1}. Ames test has shown no mutagenicity of KP irradiated with 3000 kGy or of the oily mixture of radiolytic products isolated from it. Solid KP has proven to be very stable on irradiation, and irradiation has been found to be a suitable method for its sterilization.
Authors:
Katusin-Razem, Branka; [1]  Hamitouche, Katia; [2]  Maltar-Strmecki, Nadica; [3]  Kos, Karmen; [4]  Pucic, Irina; [1]  Britvic-Budicin, Smiljana; [1]  Razem, Dusan [1] 
  1. Ruder Boskovic Institute, P.O.B 180, Zagreb 10000 (Croatia)
  2. Centre de Recherche et Developpement Saidal, El Harrach (Algeria)
  3. Faculty of Veterinary Medicine, University of Zagreb, Zagreb 10000 (Croatia)
  4. Belupo Pharmaceutical Works, Koprivnica 48000 (Croatia)
Publication Date:
Jun 01, 2005
Product Type:
Journal Article
Resource Relation:
Journal Name: Radiation Physics and Chemistry (1993); Journal Volume: 73; Journal Issue: 2; Other Information: DOI: 10.1016/j.radphyschem.2004.07.004; PII: S0969-806X(04)00456-6; Copyright (c) 2004 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); PBD: Jun 2005
Subject:
38 RADIATION CHEMISTRY, RADIOCHEMISTRY, AND NUCLEAR CHEMISTRY; CALORIMETRY; ELECTRON SPIN RESONANCE; HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY; INFRARED RADIATION; RADIATION DOSES; RADIOLYSIS; RADIOSTERILIZATION; SPECTROPHOTOMETRY; SPECTROSCOPY; ULTRAVIOLET RADIATION; X-RAY DIFFRACTION
OSTI ID:
20620282
Country of Origin:
United Kingdom
Language:
English
Other Identifying Numbers:
Journal ID: ISSN 0969-806X; RPCHDM; TRN: GB05R3104063932
Submitting Site:
GBN
Size:
page(s) 111-116
Announcement Date:
Aug 28, 2005

Citation Formats

Katusin-Razem, Branka, Hamitouche, Katia, Maltar-Strmecki, Nadica, Kos, Karmen, Pucic, Irina, Britvic-Budicin, Smiljana, and Razem, Dusan. Radiation sterilization of ketoprofen. United Kingdom: N. p., 2005. Web. doi:10.1016/j.radphyschem.2004.07.004.
Katusin-Razem, Branka, Hamitouche, Katia, Maltar-Strmecki, Nadica, Kos, Karmen, Pucic, Irina, Britvic-Budicin, Smiljana, & Razem, Dusan. Radiation sterilization of ketoprofen. United Kingdom. https://doi.org/10.1016/j.radphyschem.2004.07.004
Katusin-Razem, Branka, Hamitouche, Katia, Maltar-Strmecki, Nadica, Kos, Karmen, Pucic, Irina, Britvic-Budicin, Smiljana, and Razem, Dusan. 2005. "Radiation sterilization of ketoprofen." United Kingdom. https://doi.org/10.1016/j.radphyschem.2004.07.004.
@misc{etde_20620282,
title = {Radiation sterilization of ketoprofen}
author = {Katusin-Razem, Branka, Hamitouche, Katia, Maltar-Strmecki, Nadica, Kos, Karmen, Pucic, Irina, Britvic-Budicin, Smiljana, and Razem, Dusan}
abstractNote = {Radiation sterilization of ketoprofen (KP) dry powder was investigated by selected physico-chemical methods. High-performance liquid chromatography, ultraviolet spectrophotometry, infrared spectrophotometry, differential scanning calorimetry, X-ray diffraction and electron spin resonance spectroscopy did not show any significant degradation at sterilization dose 25 kGy. To determine the nature, extent and direction of radiation-induced changes, KP was irradiated to extremely high doses, much higher than necessary to achieve sterility. The irradiated KP did not show any difference of XRD patterns up to 200 kGy; with DSC and IR some changes were detected only above 1000 and 2000 kGy, respectively; HPLC has shown about 5% destruction at 2000 kGy. Acetyl benzophenon (AcBph) was generated by irradiation with G(AcBph)=(1.6{+-}0.1)x10{sup -8} mol J{sup -1}. Ames test has shown no mutagenicity of KP irradiated with 3000 kGy or of the oily mixture of radiolytic products isolated from it. Solid KP has proven to be very stable on irradiation, and irradiation has been found to be a suitable method for its sterilization.}
doi = {10.1016/j.radphyschem.2004.07.004}
journal = []
issue = {2}
volume = {73}
journal type = {AC}
place = {United Kingdom}
year = {2005}
month = {Jun}
}