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Furthermore, the accuracy and reproducibility of the assay in validation studies and during the stability study on every assay day provides the required confidence in the assay methodology, which is absolutely critical in any stability study. However, we felt it was appropriate to test and report results for bottles of this type, using a previously obtained supply, because they may still be available and in use elsewhere in the world.
The authors thank Pacita Sales for assistance with the initial physical study, design of the study suspension, and preparation of the study suspensions.
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