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Stability Testing

We are equipped with walk in stability chambers and cabinets which allow for stability data to be acquired for a variety of conditions. We are proficient at developing and implementing protocols to deliver high quality data which speaks for itself.

Chemika is equipped with a variety of enclosures to allow for a range in storage conditions, including photostability according to ICH protocol Q1B. Walk in enclosures are available for 25°C/60%RH, 30°C/60%RH and 2-8°C. We have a number of other cabinet style enclosures which include 40°C/75%RH and 35°C/75%RH plus spare capacity for other conditions as required. The enclosures are all temperature mapped spatially and temporally and conditions are logged continuously.

Stability studies can run from days to years and Chemika is experienced in developing and executing protocols for a variety of study durations. We also have experience in developing in-use or broached vial stability protocols and their execution.

In addition to expertise in pharmaceutical regulation and analytical chemistry, the principal Dr Alan Doughty has background in chemical kinetics and mechanisms of degradation. This can bring insight to analysis of stability data and can also allow for identification of peaks which appear over the course of the stability study. An understanding of mechanism can also allow for sound choice of analytical methods, ensuring that impurities which are degradants or particularly hazardous can be profiled in preference to compounds which may only be present as manufacturing impurities.