Comparative Delamination Study to Demonstrate the Impact of Container Quality and Nature of Buffer System.

Abstract

Delamination of flakes in glass containers used for primary drug packaging has become a serious quality concern in recent years. Because glass delamination typically occurs weeks/months after filling and there are a variety of container, processing and drug formulation factors that contribute to glass delamination, it is recommended according to USP <1660… (More)

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