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. 2020 Mar 30;5(14):7987–8000. doi: 10.1021/acsomega.0c00037

Table 10. Comparison of the Prednisolone Active Ingredient Impurity Profile with the Certificate of Analysis and the Results Obtained with the Official Ph. Eur. Method.

method used impurity F (%) impurity B (%) impurity A (%) unknown (%) unknown (%) total impurities (%)
certificate of analysis obtained by the prednisolone producer <LOQ 0.05 0.33 0.06 <LOQ 0.44
official Ph. Eur. (Table 1) (Venusil AQ C18; 150 × 4.6 mm, 3 μm) <LOQ 0.06 0.36 0.06 <LOQ 0.48
developed gradient method (Table 5) (Gemini C18; 150 × 4.6 mm, 3 μm) 0.06 0.06 0.36 0.07 0.05 0.60