OVP - PQ Test Protocol

Company: Novartis Pharmaceuticals

Operator: Admin
Instrument Type: MPA Sphere
Optics Configuration: Sphere Background with: NIR, Quartz, RT-Pbs [External]
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, 11:56:12 PM (GMT-8)
Test Date/Time: 12/11/2023, 11:56:12 PM (GMT-8)
Test Spectra Path: C:\Users\Public\Documents\Bruker\OPUS_8.7.10\Validation\Data
\20231211\235612
Date of last PQ Reference
Measurement: 12/11/2023
Comment:

Signal to Noise Test

Minimum S/N(area 1): 500 Measured S/N: 3171

100% Line Test

Maximum 100% Line Deviation: 0.5 Measured 100% Line Deviation: 0.33

Interferogram Peak Test

Minimum Amplitude[%] : 70 Measured Amplitude[%]: 105.1

Energy Test

Maximum allowed Value: 30 Measured Value: 7.7

Wavenumber Accuracy Test - BRM 2065 (36.8 Deg. C, Peak is T. corr.)

Sample Material: BRM 2065

Specified Peak: 10245.50 cm-1 Maximum Deviation: 0.60 cm-1
Measured Peak: 10245.64 cm-1
Corrected Peak: 10245.37 cm-1 Measured Deviation: 0.13 cm-1

Photometric Reproducibility Test - Glass Filter A

Maximum Deviation[%]: 0.8 Measured Deviation[%]: 0.05

Overall Test Result = PASSED

Date and Signature Date and Signature

________________
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

9000 8000 7000 6000 5000

Wavenumber cm-1
1 PQ_MPA_Sphere_Energy_1.0
2 PQ_MPA_Sphere_Energy_2.0
3 PQ_MPA_Sphere_Energy_3.0
4 PQ_MPA_Sphere_Energy_4.0
5 PQ_MPA_Sphere_Energy_5.0

1 293f924f-cff6-4ed5-b087-6b05d9670bde
2 a43338d6-98f1-4eb3-945b-32ecf3fcf812
3 d8ff5a74-a316-40d5-a846-b255e0832ed7
4 26b17ba7-72ce-4c1c-bacc-064c15d6242b
5 1e3f4567-38e7-4191-a9a6-8aa719b5345f

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

________________
Page 2 of 5 Page Signature
 OVP - PQ Test Protocol
Interferogram Peak Test, Spectrum
0.4
0.2
0.0
-0.2
-0.4

14000 12000 10000 8000 6000 4000 2000 0

Points
PQ_MPA_Sphere_Energy_1.0

293f924f-cff6-4ed5-b087-6b05d9670bde

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

________________
Page 3 of 5 Page Signature
 OVP - PQ Test Protocol
Wavenumber Accuracy Test BRM 2065 (36.8 Deg. C, Peak is T. corr.), Spectrum

10245.64
0.8
Absorbance Units
0.4 0.6
0.2

10300 10250 10200 10150

Wavenumber cm-1
PQ_MPA_Sphere_Frequency.1

8983fe8d-e1a8-45b5-ad82-62d3eba899a9

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

________________
Page 4 of 5 Page Signature
 OVP - PQ Test Protocol
Photometric Reproducibility Test - Glass Filter A, Spectrum
25
Transmittance [%]
10 15 520

10000 9000 8000 7000 6000 5000

Wavenumber cm-1
PQ_MPA_Sphere_GFA.0

8f092362-3b8a-4da5-aa5f-1d49be01ce44

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

________________
Page 5 of 5 Page Signature