Huyi Zhang

Articles by Huyi Zhang

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

ByDavid 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

ByDavid 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.

Huyi Zhang

Articles by Huyi Zhang

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

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

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