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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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM 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 0.2 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 7:35:59 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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM EST

Gradient Performance Summary Results for


Acetaminophen

Component Summary For ARTsec


SampleName Inj Vial Result Acetaminophen
Id
1 Gradient 1 2:D,8 2452 33.7
2 Gradient 2 2:D,8 2457 33.3
3 Gradient 3 2:D,8 2462 33.2
4 Gradient 4 2:D,8 2467 33.6
5 Gradient 5 2:D,8 2472 33.6
6 Gradient 6 2:D,8 2477 33.8
Mean 33.5
Std. Dev. 0.2

Gradient Performance Chromatogram Ov erlay

40000.0
Acetaminophen

30000.0
Intensity

20000.0

10000.0

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 7:35:59 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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM EST

Gradient Performance Summary Results for


Caffeine

Component Summary For ARTsec


Result
SampleName Inj Vial Id Caffeine

1 Gradient 1 2:D,8 2451 38.2


2 Gradient 2 2:D,8 2456 38.1
3 Gradient 3 2:D,8 2461 38.1
4 Gradient 4 2:D,8 2466 38.3
5 Gradient 5 2:D,8 2471 38.2
6 Gradient 6 2:D,8 2476 38.4
Mean 38.2
Std. Dev. 0.1

Gradient Performance Chromatogram Ov erlay

200000
Caffeine

150000
Intensity

100000

50000

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 7:35:59 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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM EST

Gradient Performance Summary Results for


Sulfadimethoxine

Component Summary For ARTsec


SampleName Inj Vial Result Sulfadimethoxine
Id
1 Gradient 1 2:D,8 2450 56.0
2 Gradient 2 2:D,8 2455 55.9
3 Gradient 3 2:D,8 2460 55.9
4 Gradient 4 2:D,8 2465 56.0
5 Gradient 5 2:D,8 2470 55.9
6 Gradient 6 2:D,8 2475 56.0
Mean 55.9
Std. Dev. 0.1

Gradient Performance Chromatogram Ov erlay

600000
Sulfadimethoxine

400000
Intensity

200000

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 7:35:59 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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM EST

Gradient Performance Summary Results for


Reserpine

Component Summary For ARTsec


Result
SampleName Inj Vial Id Reserpine

1 Gradient 1 2:D,8 2448 69.6


2 Gradient 2 2:D,8 2453 69.6
3 Gradient 3 2:D,8 2458 69.6
4 Gradient 4 2:D,8 2463 69.6
5 Gradient 5 2:D,8 2468 69.6
6 Gradient 6 2:D,8 2473 69.6
Mean 69.6
Std. Dev. 0.0

Gradient Performance Chromatogram Ov erlay

2.5x106
Reserpine

2.0x106

1.5x106
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 7:35:59 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_SQD2 Acquired By: sqte


Project Name: SQT_E_BSM_SM_SQD_data Column serial Number:
Sample Set Method: 070 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: 2001 Result Set Id 2417
Sample Set Name: Gradient SSM Sample Set Start Date: 12/21/2010 2:32:32 PM EST

Gradient Performance Summary Results for


Terfenadine

Component Summary For ARTsec


SampleName Inj Vial Result Terfenadine
Id
1 Gradient 1 2:D,8 2449 79.3
2 Gradient 2 2:D,8 2454 79.2
3 Gradient 3 2:D,8 2459 79.2
4 Gradient 4 2:D,8 2464 79.3
5 Gradient 5 2:D,8 2469 79.2
6 Gradient 6 2:D,8 2474 79.2
Mean 79.2
Std. Dev. 0.0

Gradient Performance Chromatogram Ov erlay

800000
Terfenadine

600000
Intensity

400000

200000

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 7:35:59 PM US/Eastern 4/26/2011 Page: 6 of 6

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