(Treffer aus pharmind, Nr. 12, Seite 1731 (2015))
Wolkerstorfer A | Buschmann H | Handler N
Scientific and regulatory aspects of solid phase reactions in forced degradation studies / Part 2
Part 1 see Pharm. Ind. 2015;77(10): 1484–1491.
: Solid phase reactions as new challenge in forced degradation studies · Wolkerstorfer A, Buschmann H, Handler N · RD&C Research, Development & Consulting, Vienna (Austria)
Forced degradation studies – also referred to as stress testing – are processes that involve degradation of drug product (DP) and drug substance (DS) at conditions more severe than at accelerated conditions and thus generate degradation products that can be studied to determine the stability of a molecule [ 1 ]. These investigations that involve exposure of DS, DP, unpackaged products and/or packaged products containing them, to specified harsher conditions of catalytic external and internal stressors of defined strength, such as heat, moisture, pH, oxidants, metal species, and light. These studies are an essential part in the design of a regulatory ...