Document Type Excel Spreadsheet (XLS)

Description PV for Stand-alone Volumetric Karl-Fischer Titration

(KFV)
Document ID 8.000.2029EN

Metrohm
Compliance Service
Operational Qualification
for Metrohm Analytical Systems (MAS)
Excel Spreadsheet for Performance Verification (PV)
for Stand-alone Volumetric Karl-Fischer Titration (KFV) Systems

Qualified Main Components

System Designation Number: #VALUE!

Product Name Serial Number

870 KF Titrino Plus
803 Ti Stand
Not Applicable (N/A)
Not Applicable (N/A)
Not Applicable (N/A)
Not Applicable (N/A)
Not Applicable (N/A)
Not Applicable (N/A)

System designation 870 Page 1 of 4

 Document Type Excel Spreadsheet (XLS)
Description PV for Stand-alone Volumetric Karl-Fischer Titration
(KFV)
Document ID 8.000.2029EN

Reagents, Standards, References

Titrant
Supplier Article-No./Lot min. shelf life Equivalent mg H2O/ml

Solvent
Supplier Article-No./Lot min. shelf life

Water Standard 10.0

Supplier Article-No./Lot min. shelf life Cert. H2O content [mg/g]

Sodium tartrate dihydrate or 2nd Water Standard 10.0

Supplier Article-No./Lot min. shelf life Cert. H2O content [%]

Balance details
Manufacturer Type Serial No./ID Calibration date

Indicator electrode details

Type Part No. Serial No./ID

Exchange / Dosing unit details

Type Part No. Serial No./ID Size [ml]

System designation 870 Page 2 of 4

 Document Type Excel Spreadsheet (XLS)
Description PV for Stand-alone Volumetric Karl-Fischer Titration
(KFV)
Document ID 8.000.2029EN

Test results
Titer determination
Sample size [g] Consump. reagent [ml] Titer [mg/ml]
Standard 1
Standard 2
Standard 3
Standard 4
Standard 5
Standard 6

Water content determination

Sample size [g] Consump. reagent [ml] H2O [%]
Sample 1
Sample 2
Sample 3

Comments

System designation 870 Page 3 of 4

 Document Type Excel Spreadsheet (XLS)
Description PV for Stand-alone Volumetric Karl-Fischer Titration
(KFV)
Document ID 8.000.2029EN

Evaluation
Titer
Theoretical value Result Pass Fail
Mean [mg/ml] N/A
sabs [mg/ml] N/A
srel [%] ≤ 2.0

Water content
Theoretical value Result Pass Fail
Mean H2O [%]
Recovery [%] 97.0 - 103.0

Metrohm representative
Yes No
Metrohm representative confirms correct execution of PV
Date Name Signature

Responsibilities
This Excel Spreadsheet has been validated.

Protocol history

Date Article No. Author Description/Changes

23/05/2011 80002011EN Axel Dellenbach Creation of file

Change of decimal places for srel from 2 to 1 in cell

C91 and F91; theoretical value for Recovery
15/07/2013 80002029EN Holger Keller specified with 1 decimal place (cell C96); re-
formatting of title; cell C95 locked. Entry fields that
are not specifically numbers are formatted as text.

End of OQ-PV document

System designation 870 Page 4 of 4