Dissolution Template
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Title of the experiment Batch #
RD-CPI-165BL-002
Mfg. Date: Jan-09
Analyst/NB REF Manoj/NB-0272
QC # LB-0216-28-40
Analysis Started:
11-Jun-08
Analysis Ended:
12-Jun-08
FOR STABILITY INFORMATION 37°C, 100 RPM, 900 mL Volume of Dissolution media, mL
water 900
Dosage, mg
420
Volume correction, mL
Apparatus 1- Baskets
8
Correction factor
Dissolution system ID # CPI-2004-05
Standard Mass (mg)
Response
2.42310 2.42430 47.4 2.42360 2.42240 2.41960 std conc. 2.42050 0.5 2.43490 47.1 2.43890 # of points Vessel
Sample Mass (mg)
Sampling Point: 1 Hour 660.9 Vessel1 663.4 Vessel2 661.7 Vessel3 659.0 Vessel4 662.8 Vessel5 663.4 Vessel6 Sampling Point: 2 Hours Vessel1 660.9 Vessel2 663.4 661.7 Vessel3 659.0 Vessel4 662.8 Vessel5 663.4 Vessel6 Sampling Point: 4 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 6 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 8 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 12 Hours Vessel1 660.9 Vessel2 663.4
Mean
Standard Purity 1.01 RSD 0.1
2.42225 RSD 2.43690 12
Standard Information NMT 2.0
% Verification 2.0 98.0%-102.0% Acceptance Criteria: per
661.9 mg of beads Amount % Dissolved Based Previously taken on label claim out (mg)
Absorbance
Concentration (mg/mL)
Average
RSD
0.11288 0.13186 0.10334 0.13587 0.12283 0.09616
0.022 0.026 0.020 0.027 0.024 0.019
0.00 0.00 0.00 0.00 0.00 0.00
4.78 5.56 4.37 5.77 5.18 4.06
5.0
13.6
0.30204 0.33355 0.28045 0.35583 0.29736 0.27886
0.060 0.066 0.055 0.070 0.059 0.055
0.18 0.21 0.16 0.21 0.19 0.15
12.71 13.99 11.79 15.02 12.49 11.69
12.9
10.1
0.86192 0.92078 0.84401 0.95582 0.85475 0.84248
0.170 0.182 0.166 0.189 0.169 0.166
0.65 0.73 0.61 0.78 0.66 0.59
35.99 38.32 35.20 40.04 35.60 35.04
36.7
5.5
1.39520 1.45980 1.39110 1.49400 1.41080 1.38460
0.275 0.288 0.274 0.295 0.278 0.273
2.01 2.19 1.94 2.28 2.01 1.92
57.97 60.44 57.71 62.28 58.44 57.29
59.0
3.3
1.75760 1.80980 1.75370 1.82880 1.77310 1.74890
0.347 0.357 0.346 0.361 0.350 0.345
4.22 4.49 4.13 4.64 4.24 4.11
72.76 74.68 72.50 75.99 73.19 72.11
73.5
2.0
2.12590 2.14590
0.419 0.423
6.99 7.35
87.66 88.22
87.8
0.9
file:///opt/pdfcoke/conversion/tmp/scratch6/24254883.xls Prepared by: __________
1
UV VIS Spectrophotometer ID # LI-3026
Confidential
1 of 2 Approved by: ___________
Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 16 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 20 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 24 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 30 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 36 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4
2.11410 2.15160 2.13450 2.11560
0.417 0.424 0.421 0.417
6.90 7.53 7.04 6.87
87.06 89.08 87.77 86.89
2.27760 2.30380 2.28360 2.29250 2.29500 2.27320
0.449 0.454 0.450 0.452 0.453 0.448
10.34 10.73 10.24 10.92 10.40 10.20
2.39370 2.41610 2.40980 2.39310 2.41810 2.39370
0.472 0.477 0.475 0.472 0.477 0.472
2.43750 2.45400 2.45720 2.43690 2.44810 2.43460
file:///opt/pdfcoke/conversion/tmp/scratch6/24254883.xls Prepared by: __________
87.8
0.9
93.74 94.53 93.84 94.75 94.18 93.18
94.0
0.6
13.94 14.37 13.84 14.54 14.03 13.79
98.35 98.97 98.84 98.75 99.05 97.94
98.7
0.4
0.481 0.484 0.485 0.481 0.483 0.480
17.72 18.18 17.64 18.32 17.84 17.57
100.07 100.45 100.71 100.48 100.23 99.55
100.2
0.4
0.000 0.000 0.000 0.000 0.000 0.000
21.56 22.05 21.52 22.16 21.70 21.41
5.14 5.24 5.13 5.30 5.16 5.09
5.2
1.5
0.000 0.000 0.000 0.000 0.000 0.000
21.56 22.05 21.52 22.16 21.70 21.41
5.14 5.24 5.13 5.30 5.16 5.09
5.2
1.5
Confidential
2 of 2 Approved by: ___________
RD-CPI-165BL-002
Mfg. Date: Jan-09
Analyst/NB REF Manoj/NB-0272
QC # LB-0216-28-40
Analysis Started:
11-Jun-08
Analysis Ended:
12-Jun-08
FOR STABILITY INFORMATION 37°C, 100 RPM, 900 mL Volume of Dissolution media, mL
water 900
Dosage, mg
420
Volume correction, mL
Apparatus 1- Baskets
8
Correction factor
Dissolution system ID # CPI-2004-05
Standard Mass (mg)
Response
2.42310 2.42430 47.4 2.42360 2.42240 2.41960 std conc. 2.42050 0.5 2.43490 47.1 2.43890 # of points Vessel
Sample Mass (mg)
Sampling Point: 1 Hour 660.9 Vessel1 663.4 Vessel2 661.7 Vessel3 659.0 Vessel4 662.8 Vessel5 663.4 Vessel6 Sampling Point: 2 Hours Vessel1 660.9 Vessel2 663.4 661.7 Vessel3 659.0 Vessel4 662.8 Vessel5 663.4 Vessel6 Sampling Point: 4 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 6 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 8 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 12 Hours Vessel1 660.9 Vessel2 663.4
Mean
Standard Purity 1.01 RSD 0.1
2.42225 RSD 2.43690 12
Standard Information NMT 2.0
% Verification 2.0 98.0%-102.0% Acceptance Criteria: per
661.9 mg of beads Amount % Dissolved Based Previously taken on label claim out (mg)
Absorbance
Concentration (mg/mL)
Average
RSD
0.11288 0.13186 0.10334 0.13587 0.12283 0.09616
0.022 0.026 0.020 0.027 0.024 0.019
0.00 0.00 0.00 0.00 0.00 0.00
4.78 5.56 4.37 5.77 5.18 4.06
5.0
13.6
0.30204 0.33355 0.28045 0.35583 0.29736 0.27886
0.060 0.066 0.055 0.070 0.059 0.055
0.18 0.21 0.16 0.21 0.19 0.15
12.71 13.99 11.79 15.02 12.49 11.69
12.9
10.1
0.86192 0.92078 0.84401 0.95582 0.85475 0.84248
0.170 0.182 0.166 0.189 0.169 0.166
0.65 0.73 0.61 0.78 0.66 0.59
35.99 38.32 35.20 40.04 35.60 35.04
36.7
5.5
1.39520 1.45980 1.39110 1.49400 1.41080 1.38460
0.275 0.288 0.274 0.295 0.278 0.273
2.01 2.19 1.94 2.28 2.01 1.92
57.97 60.44 57.71 62.28 58.44 57.29
59.0
3.3
1.75760 1.80980 1.75370 1.82880 1.77310 1.74890
0.347 0.357 0.346 0.361 0.350 0.345
4.22 4.49 4.13 4.64 4.24 4.11
72.76 74.68 72.50 75.99 73.19 72.11
73.5
2.0
2.12590 2.14590
0.419 0.423
6.99 7.35
87.66 88.22
87.8
0.9
file:///opt/pdfcoke/conversion/tmp/scratch6/24254883.xls Prepared by: __________
1
UV VIS Spectrophotometer ID # LI-3026
Confidential
1 of 2 Approved by: ___________
Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 16 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 20 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 24 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 30 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4 Sampling Point: 36 Hours Vessel1 660.9 Vessel2 663.4 Vessel3 661.7 Vessel4 659.0 Vessel5 662.8 Vessel6 663.4
2.11410 2.15160 2.13450 2.11560
0.417 0.424 0.421 0.417
6.90 7.53 7.04 6.87
87.06 89.08 87.77 86.89
2.27760 2.30380 2.28360 2.29250 2.29500 2.27320
0.449 0.454 0.450 0.452 0.453 0.448
10.34 10.73 10.24 10.92 10.40 10.20
2.39370 2.41610 2.40980 2.39310 2.41810 2.39370
0.472 0.477 0.475 0.472 0.477 0.472
2.43750 2.45400 2.45720 2.43690 2.44810 2.43460
file:///opt/pdfcoke/conversion/tmp/scratch6/24254883.xls Prepared by: __________
87.8
0.9
93.74 94.53 93.84 94.75 94.18 93.18
94.0
0.6
13.94 14.37 13.84 14.54 14.03 13.79
98.35 98.97 98.84 98.75 99.05 97.94
98.7
0.4
0.481 0.484 0.485 0.481 0.483 0.480
17.72 18.18 17.64 18.32 17.84 17.57
100.07 100.45 100.71 100.48 100.23 99.55
100.2
0.4
0.000 0.000 0.000 0.000 0.000 0.000
21.56 22.05 21.52 22.16 21.70 21.41
5.14 5.24 5.13 5.30 5.16 5.09
5.2
1.5
0.000 0.000 0.000 0.000 0.000 0.000
21.56 22.05 21.52 22.16 21.70 21.41
5.14 5.24 5.13 5.30 5.16 5.09
5.2
1.5
Confidential
2 of 2 Approved by: ___________
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