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Given how important dissolution tests are during drug development and manufacturing, dissolution tests have become key issues for regulatory bodies — which is why the dissolution equipment you depend on should deliver the most accurate, repeatable results possible. For the purposes of this article, the most common methods will be discussed (USP Apparatuses 1 and 2), including a summary of the typical method parameters to be considered in developing your dissolution method. Factors such as apparatus type, media, and rate of shaking must be evaluated, and must be suitable for the product being tested.
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