NDMA and NDEA by GC/MS on a ZB-624Plus (Valsartan Tablet #1)

GC Conditions

Column

Zebron ZB-624plus, GC Cap. Column 30m x 0.25mm x 1.4um, Ea

Part No

7HG-G040-27

Phase Name

ZB-624plus

Injection

Split 10:1 @ 150°C

Oven Program

60°C for 1 min to 240°C @ 20°C/min 240°C for 1 min

Carrier Gas

Constant Flow Helium, 36.1 cm/sec

System

Shimadzu GC System Shimadzu GC/MS System

Detection

GC/MS @ (250°C)

Detection Info

Sample Notes

500 mg Valsartan tablet (#1) analyzed and found to contain 5 ppb NDMA and 264 ppb NDEA