Vlidation, Application Bulletin Metrohm

Validation

Article	Name
AN-H-048	Standardization of disodium dimethylglyoximate for the determination of nickel
Standardization of disodium dimethylglyoximate by thermometric titration with standard Ni(II) solution.
AN-H-042	Standardization of thiosulfate titrant for copper determinations
Standardization of thiosulfate titrant for use in the determination of copper.
AB-306	A test method for the determination of the liquid efflux rate (tightness) of Metrohm Antidiffusion Tips via STAT Titration
The design of the Metrohm antidiffusion tips with the antidiffusion valve makes it possible to carry out very accurate dosing. The principle is a ‘pressure valve’ which opens synchronously with the movement of the Dosing unit piston (i.e.when the pressure in the tubing increases) and closes when the pressure in the tubing drops. This principle ensures that the volume flow stops abruptly when piston movement stops and no drop formation or titrant leakage occurs subsequently. If this mechanism is not working properly then a volume different from that documented can leak from the antidiffusion tip after the dosing step. This ‘leakage’ may also cause a delayed stabilization of the measured signal and produce faulty and inaccurate results. Metrohm recommends the use of the titrimetric volume test method described below as the Standard Operating Procedure for validating Metrohm antidiffusion tips (6.1543.200, 6.1543.130 & 6.1543.140, each with 62726.090 Antidiffusion valve). This titrimetric volume test can be used for the following purposes: Quality assurance by the manufacturer Quality assurance of analytical or other measuring systems by the user The described method is not an official reference method.
AB-283	Validation of Metrohm burets		Validation of Metrohm burets " src="http://products.metrohm.com/getAttachment.axd?attaName=b06887ad-787c-4437-b7da-90dd9196ad22&iataName=WebLarge" border="0" width="50">
Among other things, GLP (Good Laboratory Practice) requires that the accuracy and precision of analytical instruments are checked at regular intervals using Standard Operating Procedures (SOPs). Metrohm recommends the use of the gravimetric test method described below as the Standard Operating Procedure for validating Dosing and Exchange Units. This gravimetric linearity test can be used for the following purposes: • Quality assurance by the manufacturer • Quality assurance of analytical or other measuring systems by the user The described method is not an official reference method. The metrological requirements placed on piston burets, in particular the maximum permissible measurement errors, are specified in the ISO Standards 8655-1 to 8655-6.
AB-281	Validation of the 774 Oven Sample Processor in combination with a KF Coulometer by using standard operating procedures
GLP (Good Laboratory Practice) requires, among other things, the regular checking of the accuracy and precision of analytical instruments by using standard operating procedures (= SOPs). The user is recommended to validate Metrohm instruments as a whole integral measuring system, i.e. to carry out a series of determinations with certified standards and to critically assess the results by statistical means. Checking the electronic components of measuring instruments can and ought to be carried out in the context of regular service work by technical specialists from the manufacturing company. All Metrohm instruments are provided with start-up test routines that check that the relevant components are functioning properly when the instrument is switched on. If this produces no error message then it can be assumed that the instrument is functioning perfectly. Metrohm also supplies its instruments with built-in diagnosis programs that, if faults or malfunctions should occur, permit the user to check the functioning of particular assemblies and localize the fault. These diagnosis programs can also be included in a validation method. As a guideline for drawing up a standard operating procedure for checking the complete analytical system, Metrohm recommends the procedure described in this Bulletin. The limiting values mentioned should be regarded as being proposals. Depending on your company-specific requirements for the accuracy of the measuring system these limits may need to be redefined in the standard operating procedures. Articles