Influence of X-ray Radiation as PAT Method on the Model Substances Tramadol HCl and Nifedipine Compared to the Influence of UV-Vis Radiation

Rubrik: Messen/Steuern/Regeln

(Treffer aus TechnoPharm, Nr. 03, Seite 200 (2012))

Vogt M | Sternberger-Rützel E | Birke M | Jacobs C

Influence of X-ray Radiation as PAT Method on the Model Substances Tramadol HCl and Nifedipine Compared to the Influence of UV-Vis Radiation / Vogt et. al. • X-ray II · Vogt M, Sternberger-Rützel E, Birke M, Jacobs C · Robert Bosch GmbH Packaging Technology, Waiblingen und PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH, Homburg
With the introduction of X-ray technology as a measuring system (fig. 1) to control different parameters during production of medicinal products, the need to know the influence of X-ray on APIs (active pharmaceutical ingredients) was evident. In order to detect and classify the potential degradation of the API based on X-ray radiation, a reference method for comparison is needed. In order to use established methods, ICH guidelines were considered as the best choice. Therefore, the ICH guideline Q1B for photo stability testing [ 1 ] with adapted exposure times as the preferred comparison for the degradation of API by light ...