The phrase “conforms to” is a red flag, not a guarantee
A 12 × 32 mm crimp-top vial lot passed incoming QC last March. Three weeks later, a stability study showed 4.7% RSD on peak area for a preservative assay that had run at 1.1% RSD the month before. The failure was not the vial. It was the datasheet. The sheet listed a “seal tightness” value with no test method, no torque, no septum durometer, and no puncture count rating. That is the core problem with reading a vial supplier datasheet specifications and what each value means: hal...
