3.1.1 High-Performance Liquid Chromatography System (HPLC) 3.1.1.1 HPLC must have two completely independent flow paths capable of running different mobiles phases, column temperatures and detectors simultaneously. 3.1.1.2 Pump(s) 3.1.1.2.1 The pump(s) must have an over pressure limit setting. 3.1.1.2.2 The pump(s) must have an under-pressure limit setting. 3.1.1.2.3 The pump(s) must be able to detect leaks. 3.1.1.2.4 The pump(s) must be capable of solvent degassing. 3.1.1.2.5 The pump(s) must have a piston seal wash. 3.1.1.2.6 The pumps must be able to handle a psi of 15,000 at 5mL/min. 3.1.1.2.7 The pump(s) must have a flow range of a minimum 0.001 mL/min to maximum 8.0mL/min. 3.1.1.3 Autosampler 3.1.1.3.1 The autosampler must have two independent injection valves. 3.1.1.3.2 Autosampler must have a temperature range of 4°C or lower and a high temperature of 40°C or higher. 3.1.1.3.3 The injection volume must have a minimum range of 0.01 µL to 100µuL. 3.1.1.3.4 The autosampler tray must have a capacity of 200 vials (1.5 or 2mL in size) at a minimum. 3.1.1.4 Column Oven 3.1.1.4.1 The HPLC-DAD-RI system must have at a minimum two column ovens which have individual temperature controls. 3.1.1.4.2 The column oven must have a temperature range of 5°C or lower to 120°C or higher. 3.1.1.5 Diode Array Detector (DAD) 3.1.1.5.1 The DAD must have a 1024 photodiode array or better. 3.1.1.5.2 The DAD range must be 190nm to 800nm at a minimum with a minimum wavelength accuracy of ±1nm. 3.1.1.5.3 The DAD Spectral bandwidth resolution must be 0.5nm or better. 3.1.1.5.4 The DAD baseline noise must be ≤3uAU 3.1.1.5.5 The DAD drift must be ≤0.5 mAU/hr 3.1.1.5.6 The DAD must have 10 Data Channels at a minimum. 3.1.1.5.7 The DAD light source must be a deuterium lamp 3.1.1.6 Refractive Index Detector (RI) 3.1.1.6.1 The detector must have a refractive index range of 1.00 to 1.75 or broader. 3.1.1.6.2 The RI noise must be ≤1.25 nRIU 3.1.1.6.3 The RI’s drift must be ≤0.2 uRIU/h 3.1.1.6.4 The RI must have a temperature range of 30°C or lower and a high temperature of 55°C or higher.
