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In a second set of experiments tablets were stored in petri dishes (open dish) at 40 °C/75 % RH.
Similar results were observed on a different batch of tablets stored at the same conditions in an open dish (Table 5).
Up to 6 months of stability data from a 40 °C/75%RH open dish study were also included in the modeling.
The impact of temperature and RH (30 75 %) (T/RH) on dissolution at long term storage conditions was evaluated through a number of stressed and open dish studies.
Accelerated stability studies of SDFs are frequently conducted in so called "open dish" studies in which the test article is exposed to the atmosphere and equilibrates with the ambient humidity.
The dissolution of API 1 decreased to 79.9 % after storage in an open dish for 7 days at 60 °C/65 % RH and 76.8 % after 3 days at 60 °C/75 % RH.
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These open dishes were placed into large Petri dishes (18 cm in diameter) with several paper layers wetted with sterile water (100% humidity).
She buys handmade plates (4) by her friend Jody Guralnick, a New York artist who moved to Aspen and opened Dish Studio (dishstudio.com).
Fig. 4 a Predicted Water Isotherm (left) and the Predicted Water Content in the Tablets after Open-Dish Storage at 25 °C/60%RH (initial water content 4.0%%).
The result was allowed to be sampled in an open Petri dish as it underwent solvent evaporation at 40 RH% and 35 °C for 24 h, and then the samples were calcined for 1 h at various temperatures from 150 to 450 °C.
(C) A focal female observing an untrained male trying unsuccessfully to open the dish.
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