Storage condition labels explained: 2–8 °C, 15–25 °C, 'do not freeze'
Label storage conditions derive from stability studies under ICH conditions. Each phrase has a defined meaning that sets the limits for mapping, monitoring and excursion assessment.
ICH Q1A(R2) defines the storage conditions under which stability is studied: long-term at 25 °C ± 2 °C / 60 % RH ± 5 % RH or 30 °C ± 2 °C / 65 % RH ± 5 % RH, intermediate at 30 °C / 65 % RH, accelerated at 40 °C / 75 % RH, refrigerated at 5 °C ± 3 °C, and frozen at −20 °C ± 5 °C. Label statements are derived from the study results.
Reading the label
- 'Store at 2–8 °C': refrigerated; both limits matter, and freezing is an excursion.
- 'Store below 25 °C': an upper limit only; the lower limit comes from any 'do not freeze' or product-specific statement.
- 'Store at 15–25 °C': controlled room temperature with both limits.
- 'Do not freeze': a separate lower-limit requirement often applied to refrigerated products.
Mapping acceptance criteria and monitoring alarm limits should be derived from these statements for the products actually stored, not from a generic site default.
Frequently asked questions
- Is 8.2 °C an excursion for a 2–8 °C product?
- By the label, yes. Whether it matters depends on duration and the product's excursion data; the measurement uncertainty at the limit should also be considered.
References
- [1]ICH Q1A(R2): Stability Testing of New Drug Substances and Products
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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