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The course will help define the different sorts of impurities that may occur in drug substances, finished dosage forms and excipients. It will help in differentiating between degradation products and other impurities and will look at the requirements for determining degradants using validated analytical methods incorporated into regulated stability testing programs in accordance with ICH/EMA and revised FDA requirements.
Pharmaceutical impurities are easy to define, but are very diffcult to control as the recent worldwide recalls for sartan- containing drugs has demonstrated. You will look at the current and anticipated regulatory requirements related to this recent complicated challenge.
