Table 1 Scenarios used for various temperature excursion calculations

1

25 °C label storage condition with 2-year expiration date. Assume assay reaches 90% in 24 months at 25 °C.

Scenario 1a – 25 °C

Scenario 1b – 22 °C

2

25 °C label storage condition with 5-year expiration date. Assume assay reaches 90% in 60 months at 25 °C.

Scenario 2a – 25 °C

Scenario 2b – 22 °C

3

30 °C label storage condition with 2-year expiration date. Assume assay reaches 90% in 24 months at 30 °C.

Scenario 3a – 30 °C

Scenario 3b – 27 °C

4

30 °C label storage condition with 5-year expiration date. Assume assay reaches 90% in 60 months at 30 °C.

Scenario 4a – 30 °C

Scenario 4b – 27 °C