Module 3 2019

Unsuitable Starting Materials ➢ Mixtures ➢ Non-isolated intermediates ➢ Compounds that undergo few changes to make final DS: o ‘Base’ + HCl ‘Base.HCl’ (drug substance) o ‘Base’ is not a suitable starting material because of lack of GMP controls on manufacture of ‘Base’ ➢ Rule of thumb for EU is to have at least 3 isolated intermediates before DS in section 3.2.S.2.2

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