pharmaceutical impurity analysis solutions - Lcms-connect.com

Supercritical FluidChromatography (SFC)SFC, which uses supercritical CO 2as mobile phase, is another orthogonal techniquethat can be used for impurity detection because it offers HPLC-level sensitivity withreduced organic solvent usage (Figure 4). SFC also offers the advantage of chiralimpurity analysis enabling the determination of enantiomeric excess at very lowimpurity levels (Figure 5).AmAU151050-5CaffeineCaffeineMainXAgilent 1260 Infinity Analytical SFC SystemBmAU3020100-10Estriol1 2 3 4 5 minEstriolXMain1 2 3 4 5 minFigure 4. Isocratic separation of the impurity (0.05 % w/w level) from the main component (A) caffeineand(B) estriol; the signal-to-noise for the impurity at the 0.01 % level is well above 2 – 3, which is usuallythe level of detection (LOD). See Agilent publication 5990-6413EN.AmAU400R - 3RR = 1.5200SB0mAU400S - 31 2 3 4 5 6 7 8 9SR = 1.7min2000R1 2 3 4 5 6 7 8 9minFigure 5. Determination of enantiomeric excess at impurity levels below 0.05 % using SFC. Chromatogramsof R-1,1’-bi-2-napththol (A) and S-1,1’-bi-2-naphthaol (B) at 5000 ppm. See Agilent publication 5990-5969EN.12