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In case of dissolution test, if there is variation within 6
individual units however the batch is complying as per S1
criteria, is it necessary to do investigation for the same?
What should be the criteria for such variation?
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Answer / sasikumar.r
Not necessaty to investigate.....
As per USP Acceptance Criteria for
S1 is 6 Each unit is not less than Q + 5%.
If individual values passes the Q+5% means, that batch passes the dissolution..
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Answer / b.kishan reddy
Dear @Shasikumr %RSD Should be match for the 6 Units. Generally it is 5%.
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