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What should be the sampling point in dissolution test?
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There is no specific recommendation for sampling in
dissolution test. It is recommended that a specimen should
be withdraw from a zone midway between the surface of the
Dissolution Medium and the top of the rotating basket or
blade, not less than 1 cm from the vessel wall.
Where multiple sampling times are specified, replace the
aliquots withdrawn for analysis with equal volumes of fresh
Dissolution Medium at 37°C or, where it can be shown that
replacement of the medium is not necessary, correct for the
volume change in the calculation.
Specimens are to be withdrawn only at the stated times
within a tolerance of ± 2%.
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