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Study on gamma and electron beam sterilization of third generation cephalosporins cefdinir and cefixime in solid state
Authors:Babita K Singh  Dilip V Parwate  Indrani B Das Sarma  Sudhir K Shukla
Institution:1. C&C Research Laboratories, Suwon, Gyeonggi, Republic of Korea;2. College of Pharmacy, Inje University, Gimhae, Gyeongnam 621-749, Republic of Korea;3. College of Pharmacy, Seoul National University, Seoul, Republic of Korea;4. Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada;5. College of Pharmacy, and Natural Medicine Research Institute, Mokpo National University, Jeonnam 534-729, Republic of Korea;1. Merck and Co., Inc., Kenilworth, NJ, USA;2. IHMA Inc., Schaumburg, IL, USA
Abstract:The effect of gamma radiation from 60Co source and 2 MeV e-beam was studied on two thermolabile cephalosporin antibiotics viz cefdinir and cefixime in solid state. The parameters studied to assess radiolytic degradation were loss of chemical and microbiological potency, change in optical rotation, electronic and vibrational absorption characteristics, thermal behavior and color modification. ESR spectroscopic study, HPLC related impurity profile, thermogram and Raman spectrum are applied in deducing the nature of radiolytic impurities and their formation hypotheses. Cefixime is radiation sensitive, whereas cefdinir has acceptable radiation resistance at 25 kGy dose. The nature of radiolytic related impurities and their concentrations indicates that the lactam ring is not highly susceptible to direct radiation attack, which otherwise is considered very sensitive to stress (thermal, chemical and photochemical).
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