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Table 2 Stability studies/conditions used for external model validation

From: Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

Study

T (°C)

RH (%)

Time Points for Validation

Packaging Configurations

Initial Tablet Water Content

1

25

60

12 months

Aclar Blisters

2.1 %

30

65

12 months

40

75

6, 12 months

2

25

60

6, 12 months

Open Dish

4.1 %