(1994; 52 pages)
The results of the simulation study are given in Annexes 1-6. For each preparation the mean analytical results per condition are reported, with the standard deviation, coefficients of variation and the number examined.
At t=0, the initial amount of 20 tablets of each brand contained between 90-110% of the stated amount of the active ingredient and thus met BP requirements. The level of active ingredient, expressed as a percentage of the stated amount, is shown over time for each preparation and for all conditions (Annex 5). The main findings are illustrated in Annex 6, showing the level of active ingredient over time in the least (test I) and most harmful conditions (test VI) and after exposure to light. Results of the simulation studies of E and ME are given in Figures 1 to 3 and the results of OT and DOT in Figures 4-8.