High throughput technology (HTT) has been extensively used in many areas of industry. Today the formulations chemist is looking to employ HTT for Drug Stressing studies.

Forced degradation studies of new drug substances and drug products are essential to help develop and demonstrate specificity of stability-indicating methods and to determine the degradation pathways and degradation products of the active ingredients.

The ReactArray product range includes both manual and automated reaction racks to support parallel stressing studies.

Reactivate Solo
PC software for building and running methods Full graphical feedback of method progress Set point and actual temp displays for all vessels Reactivate Rack - 10 vessels with independent temperature and stirring control. Investigate multiple parameters simultaneously
Humidity Vessels
Internal cavity for solid sample to be stressed Outer chamber for water Septum closure to retain humidity and permit needle access for sampling
ReactArray Workstation for Fully Automated Stressing Studies
Automated Preparation of stressing studies Scheduler maximises throughput Automated sampling, dilution and HPLC injection Real time profile plotting Peak Tracker – monitors degradation of product and adjusts stressing conditions automatically

Example application – peak tracker in action

Peak tracker can ensure that the required degradation conditions are met automatically. The API (1,4’-diacetoxy biphenyl) was stressed with a weak solution of sodium hydroxide. Under the initial conditions without the peak tracker switched on the API was not stressed by the required 15% (Figure 1). Only the monohydroxy product was seen.

With Peak Tracker set to increase the temperature after sample point 4 if the criterion was not met, a second degradant (the dihydroxy hydrolysis product) was seen (Figure 2).

Be sure to check back for the more detailed application note.

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