OVP - PQ Test Protocol

Company: Novartis Pharmaceuticals

Operator: Admin
Instrument Type: MPA Sample Compartment
Optics Configuration: Sample Compartment with: NIR, Quartz, TE-InGaAs [Internal]
Accessory: None
Instrument Serial Number: 2006068
Instrument Firmware Version: 1.470 Oct 5 2006
OPUS/DB Version: OPUS 8.5(SP1) Build: 8, 7, 10 / DB: 8,7,10,139
Overall Test Result PASSED
Test expires: 12/11/2024, 9:02:21 PM (GMT-8)
Test Date/Time: 12/11/2023, 9:02:21 PM (GMT-8)
Test Spectra Path: C:\Users\Public\Documents\Bruker\OPUS_8.7.10\Validation\Data
\20231211\210221
Date of last PQ Reference
Measurement: 12/11/2023
Comment:

Signal to Noise Test

Minimum S/N(area 1): 4000 Measured S/N: 11047

100% Line Test

Maximum 100% Line Deviation: 0.5 Measured 100% Line Deviation: 0.25

Interferogram Peak Test

Minimum Amplitude[%] : 70 Measured Amplitude[%]: 103.8

Energy Test

Maximum allowed Value: 30 Measured Value: 4.7

Wavenumber Accuracy Test - BRM 2065 (35.4 Deg. C, Peak is T. corr.)

Sample Material: BRM 2065

Specified Peak: 10245.50 cm-1 Maximum Deviation: 0.60 cm-1
Measured Peak: 10245.69 cm-1
Corrected Peak: 10245.46 cm-1 Measured Deviation: 0.04 cm-1

Photometric Reproducibility Test - Glass Filter A

Maximum Deviation[%]: 0.8 Measured Deviation[%]: 0.06

Overall Test Result = PASSED

Date and Signature Date and Signature

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Page 1 of 5 Page Signature
 OVP - PQ Test Protocol
Signal to Noise Test, Spectra
100% Line Test, Spectra
Energy Test, Spectra
101.0
99.5 100.0 100.5
Transmittance [%]
99.0

10000 9000 8000 7000 6000 5000

Wavenumber cm-1
1 PQ_MPA_Sample_Compartment_Energy_1.0
2 PQ_MPA_Sample_Compartment_Energy_2.0
3 PQ_MPA_Sample_Compartment_Energy_3.0
4 PQ_MPA_Sample_Compartment_Energy_4.0
5 PQ_MPA_Sample_Compartment_Energy_5.0

1 aa9c1054-74b5-4fcf-ac3f-a7f3299c6973
2 9da99bb5-4550-40f2-82d3-26bd21a5314d
3 acea8d16-340d-427b-9854-3afc43f8b8bd
4 acd86fce-bece-4300-878e-0a3a6574dfea
5 3cd4bf6c-06c1-41f4-af34-dba45b9a2f59

Energy Test, Measurement Parameters

Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Power Spectrum
Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 128
Low Pass Filter: 10 KHz High Pass Filter: Open

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Page 2 of 5 Page Signature
 OVP - PQ Test Protocol
Interferogram Peak Test, Spectrum
0.25
0.15
0.05
-0.05
-0.15

14000 12000 10000 8000 6000 4000 2000 0

Points
PQ_MPA_Sample_Compartment_Energy_1.0

aa9c1054-74b5-4fcf-ac3f-a7f3299c6973

Interferogram Peak Test, Measurement Parameters

Number of Scans: 10 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Open Phase Correction: Power Spectrum
Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
Apodization Function: Blackman-Harris 3-Term Phase Resolution: 128
Low Pass Filter: 10 KHz High Pass Filter: Open

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 OVP - PQ Test Protocol
Wavenumber Accuracy Test BRM 2065 (35.4 Deg. C, Peak is T. corr.), Spectrum

10245.69
0.8
Absorbance Units
0.4 0.6
0.2

10300 10250 10200 10150

Wavenumber cm-1
PQ_MPA_Sample_Compartment_Frequency.1

f25f36ff-7a3b-45cc-b45c-07578cd28bd5

Wavenumber Accuracy Test BRM 2065 , Measurement Parameters

Number of Scans: 32 Preamplifier Gain: Ref
Resolution [cm-1]: 4 Zero filling: 8
Aperture: Filter BRM2065 Phase Correction: Power Spectrum
Acquisition Mode: Double Sided,Forward-Backward 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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 OVP - PQ Test Protocol
Photometric Reproducibility Test - Glass Filter A, Spectrum
25
Transmittance [%]
10 15 20
5

10000 9000 8000 7000 6000 5000

Wavenumber cm-1
PQ_MPA_Sample_Compartment_GFA.0

b5e0e224-8a09-49d9-bf5c-d3b1b15b23d9

Photometric Reproducibility Test - Glass Filter A, Measurement Parameters

Number of Scans: 32 Preamplifier Gain: Ref
Resolution [cm-1]: 8 Zero filling: 2
Aperture: Filter NG9 Phase Correction: Mertz
Acquisition Mode: Double Sided,Forward-Backward 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 5 of 5 Page Signature