Multistage characterization of label-derived oleamide: chromatographic purification with NMR structural elucidation and UPLC/Q-TOF-MS quantitation for pharmaceutical packaging compatibility assessment.

Pharmaceutical labeling is widely used for drug information identification, though compatibility risks persist despite no direct drug contact. This migration risk arises from the semi-permeable nature of primary packaging materials, allowing label additives to permeate into drug formulations. A substantial number of emerging additives, either novel therapeutic agents or structural mimics of prohibited substances, hinder unambiguous liquid chromatography mass spectrometry (LC-MS) identification.

Assessment on compatibility and safety of labels for pharmaceutical packaging.

Although the secondary packing materials do not directly contact the finished drug products, compound migration may still happen between them. To ensure drug quality and safety, extractables and leachables of the packing materials should be analyzed. In this study, 2,6-di-tert-butyl-4-methylphenol (BHT) was first found in the labels for pharmaceutical packaging.