Xiaochuan Yang¹, David A. Acevedo², Adil Mohammad², Naresh Pavurala³, Wei-Lee Wu⁴, Eleazar Wong⁵, Thomas O'Connor³ and Celia N. Cruz³, (1)Office of Pharmaceutical Quality, U.S. Food and Drug Administration, Silver Spring, MD, (2)U.S. Food and Drug Administration, Silver Spring, MD, (3)Office of Testing and Research, U.S. Food and Drug Administration, Silver Spring, MD, (4)Food and Drug Administration, Silver Spring, MD, (5)FDA, Silver Spring, MD