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What are Dissolution Vessels?
Good dissolution vessels are critical in obtaining correct and reproducible results and are sometimes overlooked as a key element in the dissolution test. There is no easy way to check the uniformity of the vessel. Most manufacturers provide a certificate of conformance which should be accepted. Measuring the centering of the shaft also helps. Although the USP states the dimensions for glass vessels, the tolerances are actually quite wide leading to a different dimension for vessels for each manufacturer. This means that vessels cannot easily be interchanged and that it is never advisable to substitute less than a complete set of alternative vessels and even then re-validation may be needed. All vessels should not only meet the physical dimensions but have a hemispherical bottom which means that they should be perfectly rounded with no obvious join with the sides and no ‘bumps’ of glass on the inside. Wall thicknesses should be even and reproducible. Vessels that are excessively scratched should not be used as tablet particles can get stuck in the grooves. Severely scratched vessels can also affect the dynamics of the solution. Amber vessels can be used if light sensitive compounds are being tested. Jump to section: |
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