According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*), analysis of impurity in Lamivudine should be carried out with a column filled with L45 packing material and meets following requirement. The Shodex ORpak CDBS-453 confirmed the requirement was met.

System suitability requirement:
   Resolution of  lamivudine and its enantiomer: ≥ 1.5

*The version at the time of the application acquisition. 


Sample : 10 µL
(System suitability solution) 0.25 mg/mL USP Lamivudine resolution mixture A RS in water
1. Lamivudine
2. Lamivudine enantiomer

Column       : Shodex ORpak CDBS-453 (4.6 mm I.D. x 150 mm)
Eluent       : Methanol and **Buffer (5 : 95) 
               **Buffer; 7.7 g/L of Ammonium acetate in water
Flow rate    : 1.0 mL/min
Detector     : UV (270 nm)
Column temp. : 25 °C