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Peptides MEX

Peptides MEX / Glossary

Storage at 2–8 °C: interpreting a specification

A temperature interval needs a named material, physical state and applicable period.

Updated · Sources and editorial standards

Refrigeration and stability are different facts

A 2–8 °C instruction specifies refrigerated conditions. It does not mean freezing or demonstrate that every peptide is stable within that interval. Stability evidence must match the formulation, container and conditions studied.

Sources: [1]

Read the sample state as well

A document may distinguish unopened, opened and reconstituted material. If an interval applies only to an unopened product, do not automatically extend it to a prepared solution. Record the condition, duration and documentary source separately.

Sources: [1]

Questions about this reference

Is 2–8 °C a universal rule for peptides?

No. It is a condition requiring evidence for the particular material and state described.

[1]

Sources and original reading

  1. FDA / ICH Q5C: Stability Testing of Biotechnological/Biological Products

Content updated: . How this content is prepared and checked.