New Drug Application (NDA) requires 36 month stability programmes with intensive testing at regular time intervals and differing temperatures and humidities, including moisture testing
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 solve this time consuming test easily.
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 CFR 21-11 compliant software.
Alternatively the system can be used as a stand alone instrument.
The system is capable of temperature ramps which allows different types of samples to be tested on the same run.
It is possible to test the surface water as well as the bound moisture, all you have to do is use a different temperature profile.
Samples with large moisture contents can also be analysed using a volumetric KF titrator instead of the coulometer.
If you already use freeze dried samples the heating block can be modified to suit your sample vials.
Reagent exchange is automatic so the possibility of incorrect results due to exhausted solvents is avoided.
The system can be calibrated and checked automatically daily or before each run.
