(1994; 52 pages)
The level of active ingredient in the product declined under all conditions over time. After 21 weeks under refrigerated storage (D6/83), the level of active ingredient fell below 90%. After 21 weeks at D40/75, only 63.2% of the active ingredient remained, and only 50% after 52 weeks of exposure (Figure 1).
The influence of humidity on stability was stronger than the influence of temperature (Figure 2). After 21 weeks at D30/75 the product had 64.2% of the stated amount of the active ingredient left. At 52 weeks at D40/25, 51.6% of the active ingredient was left.
In all conditions the stability of uncoated E tablets was far less than that of the coated ME tablets. Instability increased under extreme humid conditions (D30/75 or D40/75), and hot conditions (D40/25), for both E and ME. From week 31 onwards the coating no longer seems to protect the compound for stability. This seems to be the case more or less independent of the exposure condition (Figures 1,2).