Non-destructive Filling Weight Determinations for Parenteral Drug Solutions Using TD-NMR-Spectroscopy
Tobias Denk and Tobias Posset
Roche Diagnostics GmbH, Mannheim, Germany
Corresponding author: Dr. Tobias Posset, Roche Diagnostics GmbH, Sandhofer Str. 116, 68305 Mannheim, Germany, e-mail: firstname.lastname@example.org
We have shown that the filling weight of parenteral drug solutions filled into different primary packaging materials, such as syringes or vials, can be defined by using the benchtop Minispec TD-NMR machines from Bruker Optics. For this procedure different magnets (7.5 and 20 MHz) have to be used. Easy handling is important for an IPC (in-process control) method in order to use it in a routine production process. For this purpose a calibration curve based on containers filled with water is useful. It was shown in a method validation procedure that the recovery rates for the measured drug product meet the requirements for validation. Additionally we have shown that even drug product solutions filled into primary packaging materials with metallic parts, e. g. syringes with staked-in needle and vials with crimped-on caps, can be measured using optimized parameters for the TD-NMR measurement.
Key words Filling weight determination • IPC method • Non-destructive • Parenteral drug solution • Pre-filled syringes • TD-NMR
pharmind 2011, Nr. 2, Seite 383