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Table 6 ASAP data input for API 1 – dissolution at 20 min

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®)

Time (days)

T (°C)

%RH

%LC at 20 min

SD (%)

0

60

60

98.1

0.9

3

60

60

82.9

3

0

60

75

96.2

0.9

3

60

75

76.8

3

0

40

75

96.3

0.9

90

40

75

90.9

3

180

40

75

86.7

3

0

60

30

98.4

0.9

7

60

30

90

3

14

60

30

85.6

3

0

60

50

98.1

0.9

3

60

50

87.6

3

7

60

50

85.8

3

0

60

65

97.5

0.9

3

60

65

79.9

3

7

60

65

76.4

3

0

50

60

98.1

0.9

7

50

60

92.4

3

14

50

60

88.9

3

0

50

65

97.5

0.9

7

50

65

87

3

14

50

65

76.4

3

0

40

60

96.2

0.9

90

40

60

94.8

3

180

40

60

93.7

3