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Tags: Managing raw material variability

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  1. Raw material variability of an active pharmaceutical ingredient and its relevance for processability in secondary continuous pharmaceutical manufacturing

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    09 Jun 2023 | Contributor(s):: Stauffer, F, Vanhoorne, VPilcer, G, Chavez, PF, Rome, S, Schubert, MA, Aerts, L, De;Beer, T

    Active Pharmaceutical Ingredients (API) raw material variability is not always thoroughly considered during pharmaceutical process development, mainly due to low quantities of drug substance available. However, synthesis, crystallization routes and production sites evolve during product...