KF moisture analysis

Published: 1-May-2004


Metrohm has developed the 774/831 moisture analyser for essential New Drug Application (NDA work and for routine moisture analysis.

NDA work requires 36 months stability programmes with intensive testing at regular time intervals and differing temperatures and humidities. Moisture testing is one of these parameters. With several NDAs running at the same time this can lead to a lot of work and laboratory time.

The Metrohm 774/831 moisture analysis system can aid in this process because:

• 36 samples can be loaded onto the sample changer with check standards placed between samples;

• all samples are hermetically sealed so even toxic products can be analysed safely;

• tablet samples do not have to be ground in a mortar and pestle as whole tablets can be analysed.

The system is operated with 21 CFR Part 11 compliant software. Alternatively it can be used as a stand-alone instrument.

It is capable of temperature ramps, which allows different types of samples to be tested on the same run, and it is possible to test the surface water as well as the bound moisture, all using different temperature profiles.

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