Int1 Int3 RSM1 Int4 DS SM3 SM4 Int2 Int5 RSM2 DS Salt Legends SM Starting Material Int Intermediate RSM Regulatory Starting Material DS Drug substance ID: 374734
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Slide1
SM1 + SM2
Int-1
Int-3 (RSM1)
Int-4
DS
SM3 + SM4
Int-2
Int-5 (RSM2)
DS Salt
Legends
SM :
Starting Material
Int
:
Intermediate
RSM :
Regulatory Starting Material
DS : Drug substance
GMP
Regulator tendency: More steps under cGMP
Manufacturer tendency: Less steps under cGMP
Minimize quality risksControl impurities (from SM; from subsequent steps)ensure identity/purity of drug substanceMultiple purification steps more likely to purge related substances
Reduce costly GMP manufacture Reduce reporting of process variation/optimizationIncrease flexibility of process and sourcing
Non-GMP
6 Properties of API Synthesis that Affect Yield, Delivery Date &
Purity
–
Propinquity