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 .

Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?

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