OVP - OQ Test Protocol: Overall Test Result PASSED

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OVP - OQ Test Protocol

Company: Novartis Pharmaceuticals


Operator: Administrator
Instrument Type: MPA Sample Compartment
Optics Configuration: Sample Compartment w ith: NIR, Quartz, TE-InGaAs [Internal]
Accessory: None
Instrument Serial Number: MPA.0325.04
Instrument Firmw are Version: 1.300 Apr 14 2004
OPUS/DB Version: OPUS 7.2 Build: 7, 2, 139, 1294 / DB: 7,2,139,1294
Overall Test Result PASSED
Test expires: 4/18/2021, 4:30:51 PM (GMT-7)
Test Date/Time: 4/18/2020, 4:30:51 PM (GMT-7)
Test Spectra Path: C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051
Comment:

Resolution Test

Water Vapor Band: 7306.74 cm -1


Maxim um Resolution: 2.00 cm -1 Measured Resolution: 1.67 cm -1

Sensitivity Test

Measurem ent Region, Start: 6100.00 cm -1 Measurem ent Region, End: 5600.00 cm -1
Minim um S/N: 8000 Measured S/N: 12145.38

Energy Distribution Test

Minim um Energy Value: 1.00% Energy at 12000.00 cm -1 3.20%


Minim um Energy Value: 1.00% Energy at 4000.00 cm -1 54.42%

Wavenum ber Accuracy Test Water Vapor

Expected Band: 7306.740 cm -1 Measured Band: 7306.769 cm -1


Maxim um Deviation: 0.100 cm -1 Measured Deviation: 0.029 cm -1

Alignm ent Test

Interferogram Peak Range: 35000 - 28000 Measured Peak Position: 33482


Peak Am plitude: 9056

Linearity Test

Maxim um Energy[%]: 0.30 Measured Energy[%]: 0.28

Reproducibility Test

Maxim um Deviation: 2.00 Measured Deviation: 0.13

Overall Test Result = PASSED

Date and Signature Date and Signature

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Page 1 of 8 Page Signature
OVP - OQ Test Protocol
Resolution Test , Spectrum
1.201.15
Single channel
1.10 1.05

7290 7295 7300 7305 7310 7315 7320 7325


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Resolution.0

Resolution Test , M easurement Parameters


Number of Scans: 32 Preamplifier Gain: Ref
Resolution [cm-1]: 2 Zero filling: 8
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Four point Phase Resolution: 32
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 2 of 8 Page Signature
OVP - OQ Test Protocol
Sensitivity Test , Spectra
102.0101.0
Transmittance [%]
99.0 100.098.0

6100 6000 5900 5800 5700 5600


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.0
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.2
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.3
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.4
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.5
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.6
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.7
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.8
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.9

Sensitivity Test , M easurement Parameters


Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 3 of 8 Page Signature
OVP - OQ Test Protocol
Energy Distribution Test , Spectrum
0.14
0.10
Single channel
0.06 0.02

12000 11000 10000 9000 8000 7000 6000 5000 4000


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.9

Energy Distribution Test , M easurement Parameters


Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 4 of 8 Page Signature
OVP - OQ Test Protocol
Wavenumber Accuracy Test , Spectrum
0.090
0.085
Single channel
0.080 0.075

7290 7295 7300 7305 7310 7315 7320 7325


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_WvnAccuracy.0

Wavenumber Accuracy Test , M easurement Parameters


Number of Scans: 32 Preamplifier Gain: Ref
Resolution [cm-1]: 2 Zero filling: 8
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 16
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 5 of 8 Page Signature
OVP - OQ Test Protocol
Alignment Test , Spectrum
0.2
0.1
0.0
-0.1
-0.2

3750 3800 3850 3900


Points
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.9

Alignment Test , M easurement Parameters


Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 6 of 8 Page Signature
OVP - OQ Test Protocol
Linearity Test , Spectrum
0.0006
Single channel
0.0004 0.0002

4000 3500 3000 2500 2000 1500 1000


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_SN.9

Linearity Test , M easurement Parameters


Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 7 of 8 Page Signature
OVP - OQ Test Protocol
Reproducibility Test , Spectra
101.0100.5
Transmittance [%]
99.5 100.099.0

10000 9500 9000 8500 8000 7500 7000 6500


Wavenumber cm-1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.0
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.1
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.2
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.3
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.4
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.5
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.6
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.7
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.8
C:\OPUS_7.2.139.1294\Validation\Data\20200418\163051\OQ_MPA_Sample_Compartment_Reproduce.9

Reproducibility Test , M easurement Parameters


Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 64 Zero filling: 16
Aperture: Open Phase Correction: Pow er Spectrum
Acquisition Mode: Double Sided,Forw ard-Backw ard Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 8 of 8 Page Signature

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