Developing an Analytical Impurity Control Strategy …
Developing an Analytical Impurity Control Strategy Using QbD. Mark D. Argentine Quality by Design in Development Relies upon Developing knowledge around processes and products . for effective process and product design and Control . Ref: M. Nasr, 2006. IFPAC 2014 2. M. Argentine An understanding of What goes in and What goes on in development . solvent 1 solvent 2, reagent A+B C API. time, temp., (B') pH . (C') (API'). (BP1, BP2 ) (D1, D2 ). A, B = starting materials C = intermediate API = active pharmaceutical ingredient B' = starting material Impurity with potential to form C' and API'. BP = reaction by-product D = degradation product leads to knowledge and development of suitable, robust manufacturing and Analytical controls for your process IFPAC 2014 3. M. Argentine Building a Process Knowledge Base Consider multiple synthetic variations, suppliers for starting materials, etc.
An example: Analytical Design Space for Impurity Method Development . Zorbax SB C8 Bonus RP ACE Phenyl Xterra MS C18 ACE CN Atlantis dC18 Polaris C8-Ether
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