Table 1.

Storage conditions to assess thermal stability

Storage condition	Description
Long-term	Storage at 25 ± 2 °C/60 ± 5% RH for 5 days before storage at 5 ± 3 °C (claimed storage temperature) without control of RH
Long-term with short TE	Storage at 25 ± 2 °C/60 ± 5% RH for 5 days before storage at 5 ± 3 °C, followed by a final TE at 25 ± 2 °C/60 ± 5% RH for 1 month, and 28 days broached at 25 ± 2 °C/60 ± 5% RH
Long-term with long TE	Storage at 25 ± 2 °C/60 ± 5% RH for 5 days before storage at 5 ± 3 °C, followed by a final TE at 25 ± 2 °C/60 ± 5% RH for 3 months, and 28 days broached at 25 ± 2 °C/60 ± 5% RH
Accelerated	Storage at 25 ± 2 °C/65 ± 5% RH for up to 6 months
Stress	Storage at 40 ± 2 °C/75 ± 5% RH for up to 3 months

TE temperature excursion, RH relative humidity