Start from the question: how many vials from this lot do I need to test to claim that the lot meets specification, and the answer depends on both the lot size and the acceptable risk.
Under AQL sampling plans, testing two vials from a fifty-vial lot gives you an operating characteristic curve that tells you what risks you are accepting.
Published data on lot homogeneity from manufacturers who sample multiple vials consistently find variation below the published specifications, suggesting the sampling plans work.
The caveat is that sampling is a trade-off between cost and confidence, and neither test nor assumption is cost-free.
In practice: ask for the chromatogram, check the method section, check the lot number against the vial, and set your accept threshold before you see the result rather than after.
edited 7 Nov 2025 by laminar_bench — fixed an arithmetic slip in the third paragraph