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Use of a Quality-by-Design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols
Peter J. Skrdla, Tao Wang, Vincent Antonucci, Thomas Dowling, Zhihong Ge, Dean Ellison, John Curran, Ganapathy Mohan, Jean WyvrattVolume:
50
Year:
2009
Language:
english
Pages:
3
DOI:
10.1016/j.jpba.2009.06.027
File:
PDF, 105 KB
english, 2009