Deamidation, oxidation, and the two shifts worth memorising
What would be needed to catch each of these, and what it would cost.
Explainers
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A percentage is not a specification
Chromatographic purity is cheap, fast and comparable-looking. Those three properties, and not its usefulness, explain why it became the industry’s single figure of merit.
What orthogonal actually means, and what it does not
The most useful single addition to any purity determination is a second separation under a different pH or on a different stationary phase, and the second-most useful is a…
A needle is a single-use instrument
A needle blunts on first use. Reuse is uncomfortable, and it is a documented contributor to lipohypertrophy.
Attribution is the hard part
We give background rates alongside trial rates, because an event occurring during treatment is not thereby caused by it.