New Generic Analytical Method
New generic analysis methods
In addition to the already established generic GC-HS method for determining residual solvents (ICH Q3C) and HPLC method for determining nitrites (ppb range) a "Generic GC method for determining diethlyene-, propyl- and ethylene glycol was established.
Range of the method: linearity of 0.01 - 0.12 mg/mL,
Linearity for all analytes r ≥ 0.999, s/n (worst case) at 0.01 mg/mL >20