Module 3 Presentations

14/05/2024

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 above80 ° C is acceptable for α of acceptable purity?

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3.2.S.2.3 Control of Materials: Specification Setting

 Considerations apply equally to RSM and isolated intermediates (intermediate specification in 3.2.S.2.4)  Only key criteria are controlled for early use compounds: o Assay (‘potency’) o Purity (organic, inorganic, catalysts)  More testing and/or tighter limits usually apply to key intermediates or nearer to the final API  RSM and key intermediates need validated assay methods  Aim is for impurities from RSM to be ≤ 0.1% in API by control of key impurities in RSM and intermediates

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