Answer / navinpatel

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aliquots withdrawn for analysis with equal volumes of fresh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Specimens are to be withdrawn only at the stated times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%.

If we get 100% assay of an Initial sample ,and the stability studies of the same sample got 90% dissolution result, and when the same stability sample was analyzed for RS studies no impurities was found . Where the 10% Active substance were gone during dissolution analysis.Please help me in getting the conclusion.

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