Radiation sterilization of ketoprofen

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 spectroscop...

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Bibliographic Details
Published in:Radiation physics and chemistry (Oxford, England : 1993) England : 1993), 2005-06, Vol.73 (2), p.111-116
Main Authors: Katušin-Ražem, Branka, Hamitouche, Katia, Maltar-Strmečki, Nadica, Kos, Karmen, Pucić, Irina, Britvić-Budicin, Smiljana, Ražem, Dušan
Format: Article
Language:English
Subjects:
Ames test
DSC
ESR
HPLC
Ketoprofen
Radiation degradation
Radiation sterilization
XRD
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Summary: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 25kGy. 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 200kGy; with DSC and IR some changes were detected only above 1000 and 2000kGy, respectively; HPLC has shown about 5% destruction at 2000kGy. Acetyl benzophenon (AcBph) was generated by irradiation with G(AcBph)=(1.6±0.1)×10–8molJ–1. Ames test has shown no mutagenicity of KP irradiated with 3000kGy or of the oily mixure 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.
ISSN:0969-806X
1879-0895
DOI:10.1016/j.radphyschem.2004.07.004