How to fix the concentration for RS by HPLC
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Answer Posted / ram
The common procedure for fixing the LOQ is assuming u r specification as 100 % and we have to achieve LOQ below 50% of specification, here impurities are may be known or unknown.
for exm. known imp limit is 1.0 % then u should try to get LOQ below 0.5%, however if u try for very low level then it is well n good.
All unknown impurities will have spe of 0.1% limit and we have to do validation of unknown with active .
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