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The selection of the dissolution specifications (conditions and acceptance criteria) for product release is determined according to international guidelines such as USP, FDA, and the Biopharmaceutics Classification System (BCS).
dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent
Affordable
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Cost
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of Work
of Work
Automated dissolution testers draw samples at strict intervals, typically at 10, 15, 20, 30, 45, and 60 minutes
Utilizing the similarity factor (f₂) calculation to statistically compare the two dissolution curves. An f₂ value between 50 and 100 proves the curves are legally equivalent
- allows pharmaceutical companies to skip expensive human clinical trials by using laboratory dissolution tests to prove that a generic drug matches the brand-name product. This regulatory pathway relies on the Biopharmaceutics Classification System (BCS), which categorizes drug substances based on their aqueous solubility and intestinal permeability