Batch # 101 (MFD Nop` 2015)

SV Before Filtration Bulk Mixing Filling Filling

Assay
Batch # 101 Batch # 101 Batch # 101 Content Uniformity Batch # 101
Sample API
(API)
90 - 110 % Name 90 - 110 % 90 - 110 %

Zat A Zat B Zat A Zat B Sample Zat A Zat B Start Middle End
101.2 100.0 100.1 97.2 100.7 98.6 100.3 102.6 100.4 1 101.8 102.5 101.0
Top 1 Start 1 Top 1 Start
101.0 99.6 100.3 97.3 102.4 99.9 100.3 103.1 100.6 2 104.0 102.1 99.3
103.7 102.5 101.6 98.7 102.2 99.9 101.1 103.1 100.5 3 101.7 98.9 99.9
Top 2 Start 2 Top 2 Middle
102.7 101.4 100.9 98.0 102.8 98.7 100.9 103.0 100.4 4 101.9 100.1 101.3
102.6 101.3 102.7 99.9 99.9 97.5 101.7 102.2 99.4 5 103.0 96.9 100.8
Top 3 Start 3 Top 3 End
102.8 101.4 102.4 99.5 100.4 99.0 101.0 102.6 99.8 6 102.0 100.7 98.9
101.6 100.1 101.3 99.9 102.1 98.4 101.6 7 103.5 97.4 100.3
Middle 1 Middle 1 Middle 1
101.1 99.6 101.6 99.8 100.1 97.7 99.6 8 101.8 96.4 100.2
101.4 100.1 102.6 101.1 101.8 99.3 101.7 9 102.4 98.1 99.6
Middle 2 Middle 2 Middle 2
101.9 100.6 101.0 99.4 101.2 99.0 103.4 10 103.1 98.4 102.5
101.9 100.7 102.5 100.9 100.5 98.3 102.6
Middle 3 Middle 3 Middle 3
103.2 101.9 101.8 100.4 101.5 99.5 101.5
101.2 99.9 101.7 100.3 102.0 99.6 102.1
Bottom 1 End 1 Bottom 1
101.6 100.3 100.9 99.8 102.3 100.1 101.1
102.2 101.0 100.9 99.5 102.4 100.0 100.5
Bottom 2 End 2 Bottom 2
102.6 101.0 102.7 101.3 102.5 100.0 99.1
102.4 101.1 103.2 101.8 100.6 98.3 10.6
Bottom 3 End 3 Bottom 3
102.6 101.4 102.5 101.2 100.9 98.6 101.0
Minimum 101.0 99.6 Minimum 100.1 97.2 Minimum 99.9 97.5 10.6 Minimum 102.6 100.4 Minimum 101.7 96.4 98.9
Maximum 103.7 102.5 Maximum 103.2 101.8 Maximum 102.8 100.1 103.4 Maximum 103.1 100.6 Maximum 104.0 102.5 102.5
Average 102.1 100.8 Average 101.7 99.8 Average 101.5 99.0 96.1 Average 102.9 100.5 Average 102.5 99.1 100.4
RSD (%) 0.77 0.80 RSD (%) 0.89 1.32 RSD (%) 0.93 0.82 22.23 RSD (%) 0.24 0.12 RSD (%) 0.78 2.14 1.06

Batch # 102 (MFD Nop` 2015)

SV Before Filtration SV After Filtration Bulk mixing Filling Filling

Assay Batch # 102 Assay Batch # 102 Assay Batch # 102 Batch # 102 Content Batch # 102
Sample Sample Sample Assay Sample Name Uniformity
90 - 110 % 90 - 110 % 90 - 110 % 90 - 110 %
Name Name Name (API)

Zat A Zat B Zat A Zat B API Zat A Zat B Zat A Zat B Start Middle End
102.0 101.6 102.1 100.5 100.6 96.7 99.4 102.6 99.3 1 97.8 99.7 100.9
Top 1 Start 1 Top 1 Start
101.8 101.4 101.8 100.1 100.1 95.9 101.2 102.5 99.4 2 99.2 98.3 97.9
99.5 99.2 102.1 100.5 99.4 95.4 100.5 100.9 98.1 3 98.7 101.2 98.8
Top 2 Start 2 Top 2 Middle
99.6 99.2 101.0 99.3 101.3 97.3 99.7 100.2 97.3 4 99.9 101.7 97.9
102.9 102.5 101.0 99.4 100.9 96.9 103.0 101.2 98.2 5 99.0 97.6 97.5
Top 3 Start 3 Top 3 End
103.1 102.6 101.8 100.2 102.0 98.0 102.9 101.2 98.3 6 99.6 98.3 97.2
102.2 101.8 100.0 99.3 102.3 99.3 99.9 7 99.7 97.2 97.8
Middle 1 Middle 1 Middle 1
102.8 102.4 100.0 99.3 102.4 98.8 99.7 8 98.4 98.5 98.1
102.9 102.7 98.8 98.1 101.6 98.1 100.4 9 99.3 96.9 97.6
Middle 2 Middle 2 Middle 2
102.9 102.7 99.6 98.9 100.9 97.2 100.0 10 99.2 96.1 100.2
100.2 99.8 99.9 99.2 102.2 98.9 101.3
Middle 3 Middle 3 Middle 3
99.3 99.0 100.2 99.5 101.4 97.2 102.5
101.2 100.9 101.4 100.7 101.7 98.0 102.2
Bottom 1 End 1 Bottom 1
101.6 101.3 101.8 101.1 101.9 98.1 101.5
101.9 101.6 101.8 101.0 101.6 97.8 102.8
Bottom 2 End 2 Bottom 2
102.5 102.2 101.0 100.3 101.6 97.7 100.8
101.7 101.3 101.3 100.5 101.3 97.5 103.1
Bottom 3 End 3 Bottom 3
101.4 101.1 100.8 100.0 102.1 98.0 103.3
Minimum 99.3 99.0 Minimum 98.8 98.1 Minimum 99.4 95.4 100.2 Minimum 100.2 97.3 Minimum 97.8 96.1 97.2
Maximum 103.1 102.7 Maximum 102.1 101.1 Maximum 102.4 99.3 102.6 Maximum 102.6 99.4 Maximum 99.9 101.7 100.9
Average 101.6 101.3 Average 100.9 99.9 Average 101.4 97.6 101.4 Average 101.6 98.5 Average 99.1 98.5 98.4
RSD (%) 1.21 1.23 RSD (%) 0.96 0.79 RSD (%) 0.78 1.00 0.95 RSD (%) 1.20 1.02 RSD (%) 0.64 1.85 1.25
 Batch # 103 (MFD Nop` 2015)

SV Before Filtration SV After Filtration Bulk mixing Bulk mixing Bulk mixing

Assay Assay Assay Assay

Sample Batch # 103 Sample Batch # 103 Sample Batch # 103 (HSM1) Assay Sample Name Batch # 103 (HSM2) Sample Batch # 103 (HSM3)
Name 90 - 110 % Name 90 - 110 % Name 90 - 110 % 90 - 110 % Name 90 - 110 %

Zat A Zat B Zat A Zat B API Zat A Zat B Zat A Zat B API Zat A Zat B API
99.8 98.0 99.5 97.0 103.0 100.2 98.2 101.3 97.3 98.6 102.4 99.5 100.7
Top 1 Start 1 Top 1 Top 1 Top 1
99.4 97.8 100.2 97.9 101.4 98.6 97.9 102.7 98.4 98.0 103.1 100.2 100.0
100.9 99.1 98.2 95.9 103.1 100.2 102.0 102.3 99.2 98.1 102.8 99.6 103.5
Top 2 Start 2 Top 2 Top 2 Top 2
102.6 100.8 98.3 96.1 102.6 99.8 102.9 102.6 99.3 99.4 102.6 99.5 102.7
99.3 97.6 99.0 96.7 102.6 100.6 100.5 102.4 99.8 101.3 102.7 97.1 101.0
Top 3 Start 3 Top 3 Top 3 Top 3
100.2 98.5 100.6 98.4 102.7 100.8 100.4 102.0 99.3 100.6 103.5 98.0 101.8
101.4 99.7 102.7 100.5 102.9 100.4 98.5 102.7 99.0 97.9 104.0 98.4 102.8
Middle 1 Middle 1 Middle 1 Middle 1 Middle 1
100.9 98.9 102.0 99.7 103.4 100.6 97.0 102.7 98.9 97.9 103.8 98.4 101.7
100.5 98.7 101.9 99.3 103.7 100.9 101.8 102.6 99.7 102.1 103.8 100.7 101.9
Middle 2 Middle 2 Middle 2 Middle 2 Middle 2
101.2 99.4 103.0 100.6 103.3 100.5 102.8 103.1 100.0 101.7 103.4 100.5 101.1
99.9 98.2 102.7 100.5 102.4 99.7 98.6 103.2 101.1 101.0 103.8 100.8 102.3
Middle 3 Middle 3 Middle 3 Middle 3 Middle 3
100.1 98.4 104.2 101.6 102.7 100.0 98.7 103.5 101.3 101.4 103.7 100.6 102.2
101.9 100.0 101.3 99.2 101.9 99.5 100.1 101.7 99.5 103.7 103.6 101.1 103.8
Bottom 1 End 1 Bottom 1 Bottom 1 Bottom 1
101.5 99.6 100.5 98.4 102.3 99.7 99.6 101.1 98.9 104.6 103.6 101.0 103.8
100.5 98.6 101.7 99.6 102.5 99.9 99.7 100.4 96.6 102.9 104.3 101.5 103.1
Bottom 2 End 2 Bottom 2 Bottom 2 Bottom 2
101.3 99.4 101.4 99.1 101.8 99.3 99.6 99.8 96.0 102.4 104.2 101.0 103.2
101.5 99.6 103.1 100.6 101.8 99.0 101.4 102.3 99.5 103.0 103.1 98.4 98.9
Bottom 3 End 3 Bottom 3 Bottom 3 Bottom 3
103.0 101.1 101.3 99.2 102.1 99.2 102.2 102.4 99.5 102.9 103.1 98.6 98.7
Minimum 99.3 97.6 Minimum 98.2 95.9 Minimum 101.4 98.6 97.0 Minimum 99.8 96.0 97.9 Minimum 102.4 97.1 98.7
Maximum 103.0 101.1 Maximum 104.2 101.6 Maximum 103.7 100.9 102.9 Maximum 103.5 101.3 104.6 Maximum 104.3 101.5 103.8
Average 100.9 99.1 Average 101.2 98.9 Average 102.6 99.9 100.1 Average 102.1 99.1 101.0 Average 103.4 99.7 101.9
RSD (%) 1.01 0.99 RSD (%) 1.67 1.67 RSD (%) 0.60 0.65 1.78 RSD (%) 0.96 1.36 2.16 RSD (%) 0.54 1.29 1.51
 Filling Vial Filling Vial

Assay Content
Sample Bath # 103 Uniformity Bath # 103
Name 90 - 110 % (API)

Zat A Zat B Start Middle End

102.5 98.5 1 99.9 104.2 99.8
Start
103.2 99.0 2 99.4 104.0 105.0
103.2 98.8 3 97.6 96.1 103.8
Middle
103.7 99.5 4 97.3 102.2 108.2
103.5 99.3 5 105.5 104.7 101.1
End
102.8 98.5 6 104.1 100.6 105.9
7 105.2 103.1 104.2
8 103.2 107.9 101.8
9 104.8 102.0 101.7
10 95.0 98.0 94.4

Minimum 102.5 98.5 Minimum 95.0 96.1 94.4

Maximum 103.7 99.5 Maximum 105.5 107.9 108.2
Average 103.2 99.0 Average 101.2 102.3 102.6
RSD (%) 0.46 0.46 RSD (%) 3.78 3.33 3.71
Batch # 101
SV Before Filtration Assay SV After Filtration Assay Bulk Mixing Assay Filling
Assay Sample
Limits Sample Limits Sample Limits Sample Limits
Name
5.00 - 6.00 Name 5.00 - 6.00 Name 4.00 - 5.00 Name 3.00 - 7.00
Top 1 5.68 Start 1 5.71 Top 1 4.51 Start 4.78
Top 2 5.68 Start 2 5.72 Top 2 4.50 Middle 4.78
Top 3 5.68 Start 3 5.71 Top 3 4.51 End 4.80
Middle 1 5.80 Middle 1 5.74 Middle 1 4.51
Middle 2 5.80 Middle 2 5.74 Middle 2 4.51
Middle 3 5.72 Middle 3 5.72 Middle 3 4.51
Bottom 1 5.74 End 1 5.74 Bottom 1 4.51
Bottom 2 5.75 End 2 5.74 Bottom 2 4.51
Bottom 3 5.75 End 3 5.72 Bottom 3 4.51
Minimum 5.68 Minimum 5.71 Minimum 4.50 Minimum 4.78
Maximum 5.80 Maximum 5.74 Maximum 4.51 Maximum 4.80
Average 5.73 Average 5.73 Average 4.51 Average 4.79
Batch # 102
SV Before Filtration Assay SV After Filtration Assay Bulk mixing Assay Filling
Assay Sample
Limits Sample Limits Sample Limits Sample Limits
Name
5.00 - 6.00 Name 5.00 - 6.00 Name 4.00 - 5.00 Name 3.00 - 7.00
Top 1 5.72 Start 1 5.70 Top 1 4.65 Start 5.07
Top 2 5.81 Start 2 5.78 Top 2 4.54 Middle 5.08
Top 3 5.98 Start 3 5.71 Top 3 4.54 End 5.13
Middle 1 5.83 Middle 1 5.73 Middle 1 4.62
Middle 2 5.79 Middle 2 5.76 Middle 2 4.57
Middle 3 5.81 Middle 3 5.97 Middle 3 4.55
Bottom 1 5.70 End 1 5.75 Bottom 1 4.93
Bottom 2 5.72 End 2 5.71 Bottom 2 4.63
Bottom 3 5.73 End 3 5.79 Bottom 3 4.56
Minimum 5.70 Minimum 5.70 Minimum 4.54 Minimum 5.07
Maximum 5.98 Maximum 5.97 Maximum 4.93 Maximum 5.13
Average 5.79 Average 5.77 Average 4.62 Average 5.09
Batch # 103
SV Before Filtration Assay SV After Filtration Assay Bulk mixing Assay Bulk mixing HSM 2 Assay Bulk mixing HSM 3 Filling Vial
Assay Sample
Limits Sample Limits Sample Bulk mixing Sample Limits Sample Limits Value Limits
Name
5.00 - 6.00 Name 5.00 - 6.00 Name Name 4.00 - 5.00 Name 4.00 - 5.00 3.00 - 7.00
Top 1 5.68 Start 1 5.72 Top 1 Top 1 4.69 Top 1 4.62 Start 5.31
Top 2 5.70 Start 2 5.72 Top 2 4.79 Top 2 4.81 Top 2 4.70 Middle 5.25
Top 3 5.76 Start 3 5.78 Top 3 4.68 Top 3 4.65 Top 3 4.70 End 5.23
Middle 1 5.76 Middle 1 5.70 Middle 1 4.64 Middle 1 4.66 Middle 1 4.67
Middle 2 5.76 Middle 2 5.72 Middle 2 4.63 Middle 2 4.68 Middle 2 4.69
Middle 3 5.73 Middle 3 5.72 Middle 3 4.65 Middle 3 4.74 Middle 3 4.65
Bottom 1 5.86 End 1 5.81 Bottom 1 4.66 Bottom 1 4.67 Bottom 1 4.62
Bottom 2 5.76 End 2 5.82 Bottom 2 4.67 Bottom 2 4.69 Bottom 2 4.61
Bottom 3 5.75 End 3 5.85 Bottom 3 4.65 Bottom 3 4.75 Bottom 3 4.65
Minimum 5.68 Minimum 5.70 Minimum 4.63 Minimum 4.65 Minimum 4.61 Minimum 5.23
Maximum 5.86 Maximum 5.85 Maximum 4.79 Maximum 4.81 Maximum 4.70 Maximum 5.31
Average 5.75 Average 5.76 Average 4.67 Average 4.70 Average 4.66 Average 5.26
Batch # 101
15'
Dissoluton App.II
Lim: ≤ 85%
Start -1 81
Start -2 75 60' 120'
Start -3 84 Lim: 70 - 90% Lim: ≤ 75%
Start -4 81 82 88
Start -5 82 78 84
Start -6 81 79 91
Minimum 75 79 88
Maximum 84 81 88
Average 81 81 87
SD 2.81 78 84
RSD (%) 3.48 82 91
Middle-1 85 80 88
Middle-2 80 1.48 2.25
Middle-3 79 1.85 2.57
Middle-4 81 84 91
Middle-5 81 81 84
Middle-6 80 79 86
Minimum 79 81 86
Maximum 85 80 86
Average 81 79 85
SD 1.93 79 84
RSD (%) 2.38 84 91
End-1 78 81 86
End-2 78 2.05 2.16
End-3 82 2.55 2.50
End-4 79 79 82
End-5 79 79 83
End-6 79 83 87
Minimum 78 80 83
Maximum 82 80 84
Average 79 80 84
SD 1.41 79 82
RSD (%) 1.79 83 87
80 84
Batch # 102 1.27 1.65
15' 1.59 1.97
Dissoluton App.II
Lim: ≤ 85%
Batch # 101
15'
Dissoluton App.II
Lim: ≤ 85%
Start -1 80
Start -2 80 60' 120'
Start -3 81 Lim: 70 - 90% Lim: ≤ 75%
Start -4 79 79 87
Start -5 79 81 88
Start -6 77 83 88
Minimum 77 80 88
Maximum 81 80 87
Average 79 80 84
SD 1.35 79 84
RSD (%) 1.70 83 88
Middle-1 75 80 87
Middle-2 76 1.31 1.44
Middle-3 76 1.63 1.66
Middle-4 76 76 80
Middle-5 76 78 83
Middle-6 76 76 81
Minimum 75 77 81
Maximum 76 77 83
Average 76 76 80
SD 0.39 76 80
RSD (%) 0.51 78 83
End-1 77 77 81
End-2 77 0.86 1.49
End-3 77 1.12 1.83
End-4 75 78 83
End-5 76 79 83
End-6 77 78 82
Minimum 75 76 80
Maximum 77 78 82
Average 77 78 83
SD 0.87 76 80
RSD (%) 1.14 79 83
78 82
Batch # 103 0.96 1.20
15' 1.23 1.46
Dissoluton App.II
Lim: ≤ 85%
Batch # 101
15'
Dissoluton App.II
Lim: ≤ 85%
Start -1 72
Start -2 69 60' 120'
Start -3 74 Lim: 70 - 90% Lim: ≤ 75%
Start -4 73 73 81
Start -5 73 71 77
Start -6 75 75 81
Minimum 69 74 79
Maximum 75 74 80
Average 73 77 82
SD 1.88 71 77
RSD (%) 2.58 77 82
Middle-1 75 74 80
Middle-2 75 2.15 1.54
Middle-3 72 2.90 1.93
Middle-4 77 75 81
Middle-5 74 76 82
Middle-6 75 73 79
Minimum 72 77 82
Maximum 77 74 79
Average 75 76 82
SD 1.46 73 79
RSD (%) 1.96 77 82
End-1 75 75 81
End-2 79 1.52 1.21
End-3 78 2.02 1.50
End-4 76 78 84
End-5 77 79 85
End-6 77 80 87
Minimum 75 78 84
Maximum 79 78 85
Average 77 79 83
SD 1.57 78 83
RSD (%) 2.04 80 87
79 85
0.87 1.32
1.11 1.56