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A series of experiments was also performed to evaluate the lubrication performance across a range of blender fill levels, lubrication endpoints, and drug substance batches. Magnesium stearate and sodium stearyl fumarate were each passed through a #60 mesh (nominal 250 μm) screen and added to the bin blender containing the unlubricated blend. Sampling of each batch was conducted at discrete revolution time points during the process. At each revolution time point, samples were collected from six locations in the blender using a slug thief or a powder thief. [Figure 3.2.P.2-0431-tablet: 12] and [Figure 3.2.P.2-0431-tablet: 13] show the RSD for Sitagliptin Phosphate and total lubricant assay as a function of the number of revolutions. The results indicate that the drug substance uniformity achieved during the initial blend step is maintained throughout the lubrication process regardless of fill level or drug substance particle size. No evidence of demixing or segregation of the drug substance at extended blending times is observed under any blending conditions. Additionally, uniformity of the lubricants can be achieved across a wide range of fill levels and with drug substance batches of varying particle size characteristics.
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