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2. aFDA Draft Guideline, Guidance for Industry: Drug Substance: Chemistry, Manufacturing, and Controls Information;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, Jan. 2004. Withdrawn Federal Register, Notice: June 1, 2006.
3. bEMEA Guideline on the Chemistry of New Active Substances,CPMP/QWP/130/96, December 2003, Revision 1.
4. cICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities);U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, 2011.
5. Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, 1987.