Module 3 2019

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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