Module 3 2019

Why are you asked for lots of details in 3.2.S.2.2?

➢ Regulators need to know that you understand your route and its limitations (Proven Acceptable Ranges, PAR):

➢ At ~ 80°C α-form predominates (kinetic) ➢ At ~ 160°C β-form is major product (thermodynamic) ➢ As temperature rises β predominates but how much above 80 ° C is acceptable for α of acceptable purity?

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