Sample ID AA0043 AA0044 AA0045

Tab 01 103.92 103.82 103.86

Tab 02 103.68 103.34 103.38
Tab 03 104.64 102.19 102.23
Tab 04 102.68 102.71 102.75
Tab 05 105.88 103.44 103.48
Tab 06 106.58 102.79 101.95
Tab 07 104.43 102.75 102.83
Tab 08 106.37 102.15 102.79
Tab 09 105.19 102.31 102.19
Tab 10 104.64 102.49 102.53

Max. 106.58 103.820 103.860

Min. 102.68 102.150 101.950
Aver. 104.801 102.799 102.799
Std. Dev. 1.169 0.537 0.585
RSD 1.115 0.522 0.000
CPL 5.647 11.050 10.148
CPU 2.908 7.574 6.956
Cp 4.278 9.312 8.552
Cpk 2.908 7.574 6.956
Content uniformity(%)

Content uniformity
115
113
111
109
107
105
103
101
99
97
95
93
91
89
87
85
103
101
99
97
95
93
91
89
87
85
Tab 01 Tab 02 Tab 03 Tab 04 Tab 05 Tab 06 Tab 07 Tab 08

Sample ID

AA0043 AA0044 AA0045 USL

 USL LSL

115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0
115.0 85.0

25.5
25.7
25.6
25.6
ent uniformity
0.0816496581
0.3189439769
Tab 06 Tab 07 Tab 08 Tab 09 Tab 10

044 AA0045 USL LSL

Sample ID Data 1 USL LSL
Sample 01 98.50000 90.00000 110.00000
Sample 02 99.20000 90.00000 110.00000
Sample 03 97.40000 90.00000 110.00000
Sample 04 100.20000 90.00000 110.00000
Sample 05 98.40000 90.00000 110.00000

Sample 06 99.80000 90.00000 110.00000

Sample 07 98.40000 90.00000 110.00000
Sample 08 97.80000 90.00000 110.00000
Sample 09 98.50000 90.00000 110.00000
Sample 10 99.60000 90.00000 110.00000
Max. 100.2
Min. 97.4
Aver. 98.78
Std. Dev. 0.84947
RSD 0.85996
CPL -3.17702
CPU -2.48612
Cp -2.83
Cpk -3.18
 Blend Uniformity
Blend Uniformity (%) 115.00000
112.50000
110.00000
107.50000
105.00000
102.50000
100.00000
97.50000
95.00000
92.50000
90.00000
87.50000
85.00000
Sample Sample Sample Sample Sample Sample Sample Sample Sample Sample
01 02 03 04 05 06 07 08 09 10

Sample ID

Data 1 USL LSL

Sample ID Data 1 USL LSL
Sample 01 11.00000 18.00000 10.00000
Sample 02 12.00000 18.00000 10.00000
Sample 03 14.00000 18.00000 10.00000
Sample 04 16.00000 18.00000 10.00000
Sample 05 15.00000 18.00000 10.00000

Sample 06 14.00000 18.00000 10.00000

Sample 07 15.00000 18.00000 10.00000
Sample 08 16.00000 18.00000 10.00000
Sample 09 17.00000 18.00000 10.00000
Sample 10 15.00000 18.00000 10.00000
Sample 11 12.00000 18.00000 10.00000
Sample 12 15.00000 18.00000 10.00000
Sample 13 14.00000 18.00000 10.00000
Sample 14 16.00000 18.00000 10.00000
Sample 15 15.00000 18.00000 10.00000
Sample 16 14.00000 18.00000 10.00000
Sample 17 15.00000 18.00000 10.00000
Sample 18 15.00000 18.00000 10.00000
Sample 19 16.00000 18.00000 10.00000
Sample 20 14.00000 18.00000 10.00000
Max. 17
Min. 11
Aver. 14.5
Std. Dev. 1.74642
RSD 12.04431
CPL 2.61964
CPU 2.03750
Cp 2.33
Cpk 2.04
 Hardness of Core Tablets
Tablet Hardness (Kg) 18.00000
17.50000
17.00000
16.50000
16.00000
15.50000
15.00000
14.50000
14.00000
13.50000
13.00000
12.50000
12.00000
11.50000
11.00000
10.50000
10.00000
9.50000
9.00000
8.50000
8.00000
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20
e e e e e e e e e e e e e e e e e e e e
pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl
m m m m m m m m m m m m m m m m m m m m
Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa Sa

Sample ID

Data 1 USL LSL

Sample ID Results USL LSL
Sample 01 13.40000 15.00000 13.00000
Sample 02 14.20000 15.00000 13.00000
Sample 03 14.50000 15.00000 13.00000
Sample 04 14.60000 15.00000 13.00000
Sample 05 14.40000 15.00000 13.00000

Sample 06 14.00000 15.00000 13.00000

Sample 07 14.30000 15.00000 13.00000
Sample 08 14.50000 15.00000 13.00000
Sample 09 14.60000 15.00000 13.00000
Sample 10 14.50000 15.00000 13.00000
Sample 11 14.30000 15.00000 13.00000
Sample 12 14.60000 15.00000 13.00000
Sample 13 14.70000 15.00000 13.00000
Sample 14 14.50000 15.00000 13.00000
Sample 15 14.60000 15.00000 13.00000
Sample 16 14.50000 15.00000 13.00000
Sample 17 14.50000 15.00000 13.00000
Sample 18 14.60000 15.00000 13.00000
Sample 19 14.70000 15.00000 13.00000
Sample 20 14.50000 15.00000 13.00000
Max. 14.60000
Min. 13.4
Aver. 14.3
Std. Dev. 0.34928
RSD 2.44255
CPL 0.15136
CPU 0.08150
Cp 0.12
Cpk 0.08
 Length of Core Tablets
Tablet Hardness (mm)
14.90000
14.70000
14.50000
14.30000
14.10000
13.90000
13.70000
13.50000
13.30000
13.10000
12.90000
12.70000
12.50000
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20
e e e e e e e e e e e e e e e e e e e e
pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl
am am am am am am am am am am am am am am am am am am am am
S S S S S S S S S S S S S S S S S S S S

Sample ID

Results USL LSL

Sample ID Results USL LSL
Sample 01 5.40000 5.00000 5.50000
Sample 02 5.30000 5.00000 5.50000
Sample 03 5.20000 5.00000 5.50000
Sample 04 5.10000 5.00000 5.50000
Sample 05 5.20000 5.00000 5.50000
Sample 06 5.20000 5.00000 5.50000
Sample 07 5.40000 5.00000 5.50000
Sample 08 5.30000 5.00000 5.50000
Sample 09 5.20000 5.00000 5.50000
Sample 10 5.10000 5.00000 5.50000
Sample 11 5.10000 5.00000 5.50000
Sample 12 5.20000 5.00000 5.50000
Sample 13 5.30000 5.00000 5.50000
Sample 14 5.40000 5.00000 5.50000
Sample 15 5.20000 5.00000 5.50000
Sample 16 5.20000 5.00000 5.50000
Sample 17 5.20000 5.00000 5.50000
Sample 18 5.20000 5.00000 5.50000
Sample 19 5.20000 5.00000 5.50000
Sample 20 5.40000 5.00000 5.50000
Max. 5.40000
Min. 5.1
Aver. 5.24
Std. Dev. 0.10198
RSD 1.94619
CPL -0.00884
CPU -0.00816
Cp -0.01
Cpk -0.01
 Av. Thickness of Core Tablets
Av. Thickness (mm)
5.44000

5.36000

5.28000

5.20000

5.12000

5.04000

4.96000

4.88000

4.80000
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20
e e e e e e e e e e e e e e e e e e e e
pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl
am am am am am am am am am am am am am am am am am am am am
S S S S S S S S S S S S S S S S S S S S

Sample ID

Results USL LSL

Sample ID Results USL LSL
Sample 01 0.70000 1.00000 0.00100
Sample 02 0.50000 1.00000 0.00100
Sample 03 0.80000 1.00000 0.00100
Sample 04 0.40000 1.00000 0.00100
Sample 05 0.20000 1.00000 0.00100
Sample 06 0.40000 1.00000 0.00100
Sample 07 0.50000 1.00000 0.00100
Sample 08 0.50000 1.00000 0.00100
Sample 09 0.60000 1.00000 0.00100
Sample 10 0.40000 1.00000 0.00100
Sample 11 0.40000 1.00000 0.00100
Sample 12 0.60000 1.00000 0.00100
Sample 13 0.70000 1.00000 0.00100
Sample 14 0.50000 1.00000 0.00100
Sample 15 0.40000 1.00000 0.00100
Sample 16 0.10000 1.00000 0.00100
Sample 17 0.60000 1.00000 0.00100
Sample 18 0.50000 1.00000 0.00100
Sample 19 0.20000 1.00000 0.00100
Sample 20 0.40000 1.00000 0.00100
Max. 0.80000
Min. 0.2
Aver. 0.5
Std. Dev. 0.16125
RSD 32.24903
CPL 0.02682
CPU 0.02687
Cp 0.03
Cpk 0.03
 Friability of Core Tablets
0.96100
Friability (%)

0.88100
0.80100
0.72100
0.64100
0.56100
0.48100
0.40100
0.32100
0.24100
0.16100
0.08100
0.00100
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20
e e e e e e e e e e e e e e e e e e e e
pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl pl
am am am am am am am am am am am am am am am am am am am am
S S S S S S S S S S S S S S S S S S S S

Sample ID

Results USL LSL

Sample ID Data 1 USL LSL
Sample 01 6.50000 15.00000 0.00000
Sample 02 6.40000 15.00000 0.00000
Sample 03 6.50000 15.00000 0.00000
Sample 04 6.70000 15.00000 0.00000
Sample 05 7.80000 15.00000 0.00000

Sample 06 7.80000 15.00000 0.00000

Max. 7.8
Min. 6.4
Aver. 6.95
Std. Dev. 0.60759
RSD 8.74231
CPL 1.40759
CPU 1.63037
Cp 1.52
Cpk 1.41
Disintigration Time (Min)

Disintigration Time
15.00000
14.20000
13.40000
12.60000
11.80000
11.00000
10.20000
9.40000
8.60000
7.80000
7.00000
6.20000
5.40000
4.60000
3.80000
3.00000
2.20000
1.40000
0.60000
-0.20000
Sample 01 Sample 02 Sample 03 Sample 04 Sample 05 Sample 06
-1.00000

Sample ID

Data 1 USL LSL

Sample ID Data 1 USL LSL
Sample 01 92.00000 70.00000 110.00000
Sample 02 95.00000 70.00000 110.00000
Sample 03 97.00000 70.00000 110.00000
Sample 04 95.00000 70.00000 110.00000
Sample 05 94.00000 70.00000 110.00000

Sample 06 91.00000 70.00000 110.00000

Max. 92
Min. 91
Aver. 94
RSD 2.12765957
Std. Dev. 2.00000
CPL -10.66667
CPU -16.00000
Cp -13.33
Cpk -16.00
 Dissolution
Dissolution (%)

109.00000
106.00000
103.00000
100.00000
97.00000
94.00000
91.00000
88.00000
85.00000
82.00000
79.00000
76.00000
73.00000
70.00000
Sample 01 Sample 02 Sample 03 Sample 04 Sample 05 Sample 06

Sample ID

Data 1 USL LSL