New generic methods established

New Generic Analytical 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 diethylene, propyl, and ethylene glycol” has been established. 

Method range: 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

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