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How to decide restandardisation due or retest or expiry of
Volumetric solutions prepared in wet chemistry lab?
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Answer Posted / pankaj punjabi
To establish retest or expiry date of volumetric solutions
we have to conduct validation of stability study i.e.
initial (day-1) ,7,15,30 days of intervals through a
protocol. based on results we can establish retest date of
volumetric solutions.
Suppose we wont to decide validity up to 30 days,we need to
conduct stability up to 45 days,if it's stable up to 45
days (physical apperance and strength) then we will give up
to 30 days validity.
Acceptance criteria : As per EP 6.0, RSD of three replicate
analysis is NMT 0.02%
| Is This Answer Correct ? | 3 Yes | 8 No |
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