A Rapid UPLC Method to Determine a Migration Compound from Container Closure System to Drug Product

Author(s): Mugada Ravi Prasada Rao *, Paul Mogadati, Srinivas Arutla, NNVVSS Narayana Murty and Madanmohan Malapati a

Abstract: Extractable and leachable studies are playing a key role in the pharmaceutical drug product development while selecting the suitable packing material for finished dosage form. The conventional stability studies as per the ICH Q1 provide evidence on how the

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