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Keep conditions specific

Storage & handling

A compound name alone does not define a storage temperature or shelf life.

Record the material before the temperature

Identify the exact compound, sequence or complex, salt or counterion, supplied form, batch and container. A lyophilized material, a solution and a multi-component blend are different stability questions.

Use the product-specific instruction

Record the supplier’s stated temperature, light and moisture conditions, packaging and any documented time limit. If the material has undergone additional laboratory processing, establish conditions for that new state rather than extending the unopened product’s instruction by assumption.

Separate storage guidance from stability evidence

A handling instruction is not a complete stability study. Ask which analytical attributes were measured, under which conditions, for how long and against which criteria. Avoid assigning a universal shelf life to a compound based on a different product’s instructions.

A useful laboratory record

  • Material identity, supplied form and lot.
  • Original certificate and product-specific handling document.
  • Container and documented environmental conditions.
  • Dates of receipt, opening and changes to material state.
  • Any observed deviation and the decision recorded by the laboratory.

Use the source-linked storage lookup · Read the extended stability guide

Source framework

  1. ICH Q1A(R2): Stability Testing of New Drug Substances and Products — general stability-study principles, not a shelf-life certificate for these materials