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Impurity Analysis of Voriconazole According to USP-NF Method (CDBS-453)

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According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*), analysis of voriconazole and its related substance B should be carried out with a column filled with L45 packing material and meets following requirements. The ORpak CDBS-453 confirmed the requirements were met.

System suitability requirements:>   Resolution of  voriconazole and related substance B: ≥ 4.0
   Tailing factor of related substance B: ≤ 2.0
   Relative standard deviation (RSD): ≤ 10.0%

*The version at the time of the application acquisition.


Sample : 20 µL
(System suitability solution A)
1. Voriconazole 500 µg/mL
2. Voriconazole related compound B 2.5 µg/mL


Column       : Shodex ORpak CDBS-453 (4.6 mm I.D. x 150 mm)
Eluent       : Acetonitrile and **Buffer (13:87) 
               **Buffer; 0.8 g/L of ammonium acetate. 
                Adjust with glacial acetic acid to a pH of 5.0. 
Flow rate    : 0.9 mL/min
Detector     : UV (256 nm)
Column temp. : 20 °C

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