Twenty-eight days at 30 °C is about 158 refrigerated days of equivalent exposure. 30 °C is 25 kelvin above the 5 °C middle of a 2–8 °C refrigerator. The ten-degree rule of thumb — degradation rate roughly doubling per 10 K — makes that about 5.7 times the refrigerated rate, which is an order-of-magnitude statement and not a shelf life. At 158 equivalent days you are outside what the original certificate speaks to, and a content assay is the test that changes your arithmetic — purity can look untouched while the milligrams have moved. Either way, record the twenty-eight days and the temperature now, while you still know them; an excursion you did not write down is an excursion you cannot interpret later.
Answer first: for a lyophilised solid the cold chain matters far less than people believe, and for a solution it matters far more than they act as though it does.
Arrhenius behaviour means the degradation rate roughly doubles per ten degrees. A week at thirty degrees is therefore a meaningful exposure for a solution and an immaterial one for a dry solid.
The relevant detail is that a single-use temperature logger costs a few pounds, records the whole journey and converts an argument into a record. If the history matters, this is the answer.
The caveat is that a warm transit is survivable for a solid and materially different for a solution.
Solutions are a different question and deserve the worry the solids get.
8Two lots stored differently, reassayed at a year — the difference was smaller than I expected. – bea_castellanos 5 months ago add a comment