David J. Skanchy

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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.

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Appendix: Common Deficiencies Related to Solution NMR in the Type-II DMFs

David J. Skanchy;Huyi Zhang;Jizhou Wang;Neeru Takiar
February 2nd 2017

Appendix to Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs, Part I: Solution Nuclear Magnetic Resonance Spectroscopy

Pages-from-PTeBook0316_046-054_Generics_DMFs_Subburaj.jpg

Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances

David J. Skanchy;Kandasamy Subburaj;Srinivasa Murthy;Humcha Hariprakasha;Brian T. Connell;Huyi Zhang;Deborah F. Johnson
March 15th 2016

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

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