Entries by Markus Limberger

Expansion Stability Center

Expansion Stability Center Further climates have now been established in the Quasaar Stability Center: – Second big volume climatic chamber 120 m³ for ICH condition 30°C, 75% RH established – Two climate chambers for stress conditions (50°C, 50% RH, and 55% RH) – Option for storing narcotics in a 50 m³ safe

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 […]