Module 3 2019

Final Route Selection - 2 ➢ Usually multiple routes to the API

o Not all are industrially feasible (cost, difficulty, safety) o Prefer convergent synthesis for yield (cost) reasons o Patent infringement issues ➢ Choice is dictated by inter alia o Starting materials (availability, cost, purity, GMP status) o Reagents (availability, cost, purity, safety) o Plant capabilities and availability – general or specialist (eg high pressure hydrogenation may be contracted out) ➢ Cost of API affects cost of goods and hence profit margin and possibly reimbursement price

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