Research Article

Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product

Table 1

Optimized parameters of elemental analyzer for quantitation of ECD in ECD Kit.

Parameters

Operation modeCHNS
Combustion temperature (°C)1150
Reduction temperature (°C)900
Flush gas/time (sec)He/10
O2 dosing time (sec)120
Column standby temperature (°C)
 CO2Ambient temperature
 H2OAmbient temperature
 SO2140
Column desorption temperature (°C)
 CO2240
 H2O150
 SO2220
Carrier gas/Flow rate (mL/min)(1)He/230
Flow rate of O2 (mL/min)15
Flow rate of O2 during combustion (mL/min)30–35

(1)Same as the mass flow control (MFC) TCD flowing gas and flow rate.