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Updated: Jun 19, 2026
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Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Radiostability of florfenicol in the solid state
Barbara Marciniec1, Maciej Stawny, Piotr Kachlicki
1Department of Pharmaceutical Chemistry, Karol Marcinkowski University of Medical Sciences, 6 Grunwaldzka, 60-780 Poznań, Poland. bmarcin@ump.edu.pl
Summary
Florfenicol (FF) is stable enough for sterilization with high-energy radiation up to 25 kGy. Minor radiodegradation occurs, but physicochemical properties and therapeutic efficacy remain intact for safe sterilization.
Area of Science:
- Pharmaceutical Science
- Radiation Chemistry
Background:
- Florfenicol (FF) is a broad-spectrum antibiotic.
- Investigating radiation sterilization is crucial for pharmaceutical applications.
Purpose of the Study:
- To assess the radiostability of florfenicol (FF) when exposed to electron beam (E-beam) radiation.
- To determine if FF can be effectively sterilized using high-energy radiation without compromising its properties.
Main Methods:
- Irradiation of FF with E-beam radiation at doses ranging from 25 to 800 kGy.
- Analysis of physico-chemical changes using chromatography (TLC, HPLC) and spectroscopy (NMR, MS).
- Identification of radiolysis products and quantification of FF degradation.
Main Results:
- A sterilizing dose of 25 kGy caused minimal FF content decrease (0.95%) and formation of two radiolysis products.
- Higher doses increased FF degradation and the number of radiolysis products.
- No spectral differences were observed between irradiated and non-irradiated FF samples.
- Radiodegradation primarily involved amide bond breaking, leading to 4-methylsulfonylbenzoic acid formation.
Conclusions:
- Florfenicol (FF) exhibits good radiostability at sterilization doses (≤25 kGy).
- High-energy radiation is a viable sterilization method for FF, preserving its physicochemical properties and therapeutic efficacy.
- The study provides critical data for the radiation sterilization of florfenicol in pharmaceutical manufacturing.
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