Title of the experiment

Batch #

RD-CPI-165BL-002

QC # LB-0216-28-40

Mfg. Date: Jan-09

Analyst/NB REF Manoj/NB-0272

Analysis Started:

11-Jun-08

Analysis Ended:

12-Jun-08

FOR STABILITY INFORMATION

37C, 100 RPM, 900 mL
Volume of Dissolution media, mL

water
900

Dosage, mg

420

Volume correction, mL

Apparatus 1- Baskets

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

Vessel1
660.9
Vessel2
663.4
Vessel3
661.7
Vessel4
659.0
Vessel5
662.8
Vessel6
663.4
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

Standard Purity

Mean

1.008
RSD
0.1

2.42225
RSD
2.43690
12

Standard Information
NMT 2.0

% Verification
2.0
98.0%-102.0%
Acceptance Criteria:
661.9 mg of beads

per

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

0.419

6.99

87.66

87.8

0.9

\\vboxsrv\conversion_tmp\scratch_3\182787720.xls.ms_office

Prepared by: __________

UV VIS Spectrophotometer ID # LI-3026

Confidential

1 of 2

Approved by: ___________

Vessel2
663.4
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
663.4
Vessel6

2.14590
2.11410
2.15160
2.13450
2.11560

0.423
0.417
0.424
0.421
0.417

7.35
6.90
7.53
7.04
6.87

88.22
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

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

\\vboxsrv\conversion_tmp\scratch_3\182787720.xls.ms_office

Prepared by: __________

2 of 2

Confidential

Approved by: ___________