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Pharmaceutical Technology
Pharmaceutical Technology-03-15-2016Volume2016 eBook Issue 1
Pages: s46-s54
Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
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The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.
Read this articlefrom Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.
View other articles in the
2016 Solid Dosage Drug Development and Manufacturing eBook.Articles in this issue
Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence Spectrometry
Optimizing Tablet Compression
Excipient Quality and Selection
Filling the Analysis Gap in the Move to Continuous Processing
Regulatory Considerations for Controlling Intermediates in Type-II Drug Master Files for the Manufacture of Generic Drug Substances
Modeling and Simulation Move Downstream
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