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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
David J. Skanchy, PhD, is a review chemist with the US Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, tel. 240.276.8552, fax 240.276.8582.
February 02, 2017
Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy
March 15, 2016
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.