Identification Of An Unknown Leachable Species From BFS Vials

An unknown leachable species was detected by GC-MS analysis of an alkaline drug product (pH approximately 10.5) that was packaged in a novel self- contained plastic Blow Fill Seal (BFS) vial.  Due to the high pH of the drug product formulation, it could not be stored in untreated glass vials.  Treated glass vials are more expensive and are prone to delamination and particulate formulation.

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