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Radiosensitivity study of cefazolin sodium
A S Crucq1, C Slegers, V Deridder
1Unité d'Analyse Chimique et Physico-Chimique des Médicaments, UCL-7230, unité CHAM - Université Catholique de Louvain 72, Avenue E. Mounier, B-1200 Louvain en Woluwe, Bruxelles, Belgium.
Talanta
|October 31, 2008
Summary
Gamma irradiation of cefazolin sodium significantly increased impurities and caused a yellow discoloration, impacting its quality. While most physico-chemical properties remained within pharmacopoeial limits, the color change requires attention for irradiated cefazolin sodium.
Area of Science:
- Pharmaceutical Chemistry
- Radiation Chemistry
- Analytical Chemistry
Background:
- Cefazolin sodium is a widely used cephalosporin antibiotic.
- Understanding the impact of sterilization methods like irradiation is crucial for drug quality and safety.
- Physico-chemical stability of antibiotics affects their efficacy and shelf-life.
Purpose of the Study:
- To investigate the physico-chemical changes in cefazolin sodium after gamma irradiation.
- To assess the impact of irradiation on cefazolin sodium's potency, impurity profile, color, and pH.
- To determine if irradiated cefazolin sodium meets European Pharmacopoeia specifications.
Main Methods:
- Potency determination using standard assays.
- Impurity profiling via chromatography to identify and quantify related substances.
- Color measurements of both powder and solution.
- pH measurements of cefazolin sodium solutions.
Main Results:
- Irradiation at 25 kGy reduced cefazolin sodium potency by 4+/-2%.
- Total related substances increased from 0.72% to 4.9%, with 7-aminocephalosporanic acid identified as a radiation-specific impurity.
- Irradiated cefazolin sodium powder turned yellow, a color that persisted in solution, failing pharmacopoeial specifications for solution color.
Conclusions:
- Gamma irradiation induces significant physico-chemical changes in cefazolin sodium, notably increasing impurities and causing discoloration.
- While potency and pH largely remained within acceptable limits, the observed yellowing of the solution is a critical deviation.
- Further studies are needed to evaluate the toxicological profile of the new impurities and the clinical implications of using irradiated cefazolin sodium.
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