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GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

The Gradient Performance qualification injects six replicates of a five component mixture. The components are
separated with a 2.5 minute gradient using Acetonitrile in the B Pump.

The standard deviation of the Retention Time for each component is reported for all six injections.
The qualification passes if the SD for the retention time for all five components is < or = 1.0 seconds.

Gradient Performance Ov erall Test Result

Retention Time (Seconds) Retention Time (Seconds)


Retention Time (Seconds)
Name Standard Deviation Standard Deviation
Standard Deviation
Specification Pass Fail
1 Acetaminophen SD RT < or = 1.0sec 0.1 PASS
2 Caffeine SD RT < or = 1.0sec 0.1 PASS
3 Sulfadimethoxine SD RT < or = 1.0sec 0.1 PASS
4 Reserpine SD RT < or = 1.0sec 0.0 PASS
5 Terfenadine SD RT < or = 1.0sec 0.0 PASS

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 1 of 6


GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

Gradient Performance Summary Results for


Acetaminophen

Component Summary For ARTsec


SampleName Inj Vial Result Acetaminophen
Id
1 Gradient 1 2:D,8 3045 32.4
2 Gradient 2 2:D,8 3050 32.2
3 Gradient 3 2:D,8 3055 32.4
4 Gradient 4 2:D,8 3060 32.2
5 Gradient 5 2:D,8 3065 32.4
6 Gradient 6 2:D,8 3070 32.4
Mean 32.4
Std. Dev. 0.1

Gradient Performance Chromatogram Ov erlay

1.5x106
Acetaminophen
Intensity

1.0x106

5.0x105

0.0
0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Minutes
SampleName Gradient; Injection 1
SampleName Gradient; Injection 2
SampleName Gradient; Injection 3
SampleName Gradient; Injection 4
SampleName Gradient; Injection 5
SampleName Gradient; Injection 6

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 2 of 6


GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

Gradient Performance Summary Results for


Caffeine

Component Summary For ARTsec


SampleName Inj Vial Result Caffeine
Id
1 Gradient 1 2:D,8 3044 37.6
2 Gradient 2 2:D,8 3049 37.5
3 Gradient 3 2:D,8 3054 37.6
4 Gradient 4 2:D,8 3059 37.5
5 Gradient 5 2:D,8 3064 37.5
6 Gradient 6 2:D,8 3069 37.5
Mean 37.5
Std. Dev. 0.1

Gradient Performance Chromatogram Ov erlay

4x107
Caffeine

3x107
Intensity

2x107

1x107

0
0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Minutes
SampleName Gradient; Injection 1
SampleName Gradient; Injection 2
SampleName Gradient; Injection 3
SampleName Gradient; Injection 4
SampleName Gradient; Injection 5
SampleName Gradient; Injection 6

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 3 of 6


GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

Gradient Performance Summary Results for


Sulfadimethoxine

Component Summary For ARTsec


SampleName Inj Vial Result Sulfadimethoxine
Id
1 Gradient 1 2:D,8 3043 56.8
2 Gradient 2 2:D,8 3048 56.8
3 Gradient 3 2:D,8 3053 56.9
4 Gradient 4 2:D,8 3058 56.9
5 Gradient 5 2:D,8 3063 56.9
6 Gradient 6 2:D,8 3068 56.9
Mean 56.9
Std. Dev. 0.1

Gradient Performance Chromatogram Ov erlay


Sulfadimethoxine

8x107

6x107
Intensity

4x107

2x107

0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80


Minutes
SampleName Gradient; Injection 1
SampleName Gradient; Injection 2
SampleName Gradient; Injection 3
SampleName Gradient; Injection 4
SampleName Gradient; Injection 5
SampleName Gradient; Injection 6

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 4 of 6


GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

Gradient Performance Summary Results for


Reserpine

Component Summary For ARTsec


Result
SampleName Inj Vial Id Reserpine

1 Gradient 1 2:D,8 3041 60.7


2 Gradient 2 2:D,8 3046 60.7
3 Gradient 3 2:D,8 3051 60.7
4 Gradient 4 2:D,8 3056 60.7
5 Gradient 5 2:D,8 3061 60.7
6 Gradient 6 2:D,8 3066 60.7
Mean 60.7
Std. Dev. 0.0

Gradient Performance Chromatogram Ov erlay

5x107
Reserpine

4x107

3x107
Intensity

2x107

1x107

0
0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Minutes
SampleName Gradient; Injection 1
SampleName Gradient; Injection 2
SampleName Gradient; Injection 3
SampleName Gradient; Injection 4
SampleName Gradient; Injection 5
SampleName Gradient; Injection 6

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 5 of 6


GRADIENT PERFORMANCE REPORT

A C Q U I S I TI O N I N F O R M A TI O N
System Name: BSM_SM_TQD Acquired By: sqte
Project Name: SQT_E_BSM_SM_TQD_data Column serial Number:
Sample Set Method: 080 Gradient SSM Sample Kit 1 Expiration Date:
Processing Method Gradient PM Sample Kit 1 Lot Number:
Report Method Name: Gradient RM Build Version: Empower 2 Software Build 2154 SPs
User Name: System Sample Set Id: 2788 Result Set Id 3010
Sample Set Name: Gradient SSM Sample Set Start Date: 1/5/2011 12:13:18 AM EST

Gradient Performance Summary Results for


Terfenadine

Component Summary For ARTsec


SampleName Inj Vial Result Terfenadine
Id
1 Gradient 1 2:D,8 3042 68.2
2 Gradient 2 2:D,8 3047 68.2
3 Gradient 3 2:D,8 3052 68.2
4 Gradient 4 2:D,8 3057 68.2
5 Gradient 5 2:D,8 3062 68.2
6 Gradient 6 2:D,8 3067 68.2
Mean 68.2
Std. Dev. 0.0

Gradient Performance Chromatogram Ov erlay


Terfenadine

4x107
Intensity

2x107

0
0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80
Minutes
SampleName Gradient; Injection 1
SampleName Gradient; Injection 2
SampleName Gradient; Injection 3
SampleName Gradient; Injection 4
SampleName Gradient; Injection 5
SampleName Gradient; Injection 6

Printed 8:13:03 PM US/Eastern 4/26/2011 Page: 6 of 6

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