This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products. In this context, a small molecule is defined as a medicinal drug compound having a molecular weight of less than 2000 Daltons, with two main exceptions. The first exception is any medicinal drug compound comprised of peptide sequences and the second exception are small molecule products produced using sterilisation by filtration that is followed by aseptic filling. For Biopharmaceuticals please refer to A Standard Protocol for Deriving and Assessment of Stability: Part 2 – Aseptic Preparations (Biopharmaceuticals).

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