Article
Mechanistic Studies Of Degradant Formation For Two Pharmaceutically Active Steroid Succinate Compounds
December 6, 2007
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•Mechanistic Studies Of Degradant Formation For Two Pharmaceutically Active Steroid Succinate Compounds
Implementation of new ICH guidelines has produced a need for a greater number of impurities to be identified. Therefore, identification of unknown impurities and degradation products in pharmaceutical drug products and substances is a ubiquitous problem that can often bring development programs to a halt. Rapid structural elucidation is thus desired, and mass spectrometry is frequently relied upon as the tool of choice. Identification of the unknown, however, is sometimes only half the story. It is just as important to understand why the unknown is forming so as to control its future appearance and perhaps eliminate its formation.
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•Mechanistic Studies Of Degradant Formation For Two Pharmaceutically Active Steroid Succinate Compounds
SOURCE: Hospira One 2 One
This information was initially presented at AAPS 2007 in San Diego, CA.
