Hello, I'm new and looking to learn more about testing.
ICP-MS elemental impurities (As, Cd, Hg, Pb, Ni, Cu, Cr, Pd) with numeric results (ppb/ppm)
Endotoxin (LAL)
Sterility or bioburden
Residual solvents (USP <467>)
Counter-ion quantification (e.g., TFA vs acetate)
Karl Fischer water content
Orthogonal HPLC methods + LC-MS identity (mass + sequence confirmation)
Maybe this is overkill. Any thoughts are appreciated. Thank you for your time.
ICP-MS elemental impurities (As, Cd, Hg, Pb, Ni, Cu, Cr, Pd) with numeric results (ppb/ppm)
Endotoxin (LAL)
Sterility or bioburden
Residual solvents (USP <467>)
Counter-ion quantification (e.g., TFA vs acetate)
Karl Fischer water content
Orthogonal HPLC methods + LC-MS identity (mass + sequence confirmation)
Maybe this is overkill. Any thoughts are appreciated. Thank you for your time.