WitrynaWydział Matematyki, Fizyki i Informatyki Uniwersytetu Gdańskiego. ul. Wita Stwosza 57, 80-308 Gdańsk. tel.: + 48 58 523 20 27 [email protected]. Portiernia: + 48 58 523 … WitrynaTimeline for USP<231> Replacement Method 1995: 1st Pharmacopeial Forum (PF) “Stimuli to the Revision Process” article (K. Blake) 2000: 2nd PF Stimuli article proposed ICP-MS (T. J. Wang) 2005: USP heavy metals subcommittee appointed 2005: ICP-MS Included in Chinese Pharmacopeia 2009: ICP-MS Included in European …
Zarządzenie nr 25/R/20 Rektora Uniwersytetu Gdańskiego z dnia …
WitrynaA general concept of qualification of impurities is described in the guidelines for active substances (Q3A, Impurities in New Active Substances) or medicinal products (Q3B, … WitrynaIn the context of this guideline, the classi fication of a compound (impurity) as genotoxic in general indicates that there are positive findings in established in vitro or in vivo genotoxicity tests with the focus on DNA reactive substances that have a potential for direct DNA d amage. five technological products
STATUT UNIWERSYTETU GDAŃSKIEGO z dnia 13 czerwca 2024 roku
Witrynathe presence of nitrosamine impurities in human medicines containing chemically synthesised active pharmaceutical ingredients (APIs). The procedure was foreseen to run in a 2-step approach as follows: • 1 st phase, to provide considerations for marketing authorisation holders (MAHs) of these medicines Witryna6 maj 2010 · • API spiked with impurity • Possible if at least 250 µg of impurity present in standard Ames test • Risk of repeating Ames test on previously negative API • Neat impurity • Time and resources to synthesize • Will have its own impurity profile *Kenyon MO et al. Regul Toxicol Pharmacol 48: 75-86, 2007. 23 Witryna1 kwi 2024 · AKTUALNY SPIS JEDNOSTEK UG wraz z symbolami 01.04.2024-31.08.2024. 968.03 KB. Administracja Centralna i Jednostki Ogólnouniwersyteckie. … five techniques of neutralization