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Table 4 Consecutive days of temperature excursion that result in a loss of approximately 15 days of shelf-life for each respective scenario

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

19

3

1

<1

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

16

3

<1

<1

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

215

49

17

6

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

510

124

41

16

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

n/a

7

2

< 1

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

n/a

6

1

<1

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

n/a

100

30

11

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

n/a

240

74

27