Skip to main content

Table 3 Days of shelf-life lost per day of excursion as a function of excursion temperature for each scenario (taken from the region of the curves for each temperature excursion with a positive slope within each respective figure)

From: Mean kinetic temperature evaluations through simulated temperature excursions and risk assessment with oral dosage usage for health programs

Label Claim Storage / Shelf-life / Long Term Storage

30 °C

40 °C

50 °C

60 °C

Scenario 1a (Fig. 1) – 25 °C / 2 years / 25 °C

0.72

3.77

11.71

28.66

Scenario 2a (Fig. 1) - 25 °C / 5 years / 25 °C

0.73

3.72

11.50

27.26

Scenario 1b (Fig. 3) - 25 °C / 2 years / 22 °C

0.98

2.22

11.99

29.70

Scenario 2b (Fig. 3) - 25 °C / 5 years / 22 °C

1.00

4.18

12.41

32.17

Average (± 1 SD) for product with 25 °C storage condition

0.86 (±0.16)

3.48 (±0.86)

11.90 (±0.39)

29.45 (±2.07)

Scenario 3a (Fig. 2) - 30 °C / 2 years / 30 °C

n/a

1.79

6.34

17.14

Scenario 4a (Fig. 2) - 30 °C / 5 years / 30 °C

n/a

1.83

6.53

17.75

Scenario 3b (Fig. 4) - 30 °C / 2 years / 27 °C

n/a

2.06

6.65

17.62

Scenario 4b (Fig. 4) - 30 °C / 5 years / 27 °C

n/a

2.10

6.30

18.16

Average (± 1 SD) for product with 30 °C storage condition

n/a

1.94 (±0.16)

6.45 (±0.16)

17.67 (±0.42)