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If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?
773analytical method validation require to with respect to release specification or shelf life specification?
793in monograph 7 imp are there but in vendor showing 5 imp do not req to include 2 imp for that what will be justification?
723In which situation we require to prepare the standard solution from sample in Related substance method?
777Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
707Post New Analytical Chemistry Questions
What is related substance by HPLC impurity limits as per USP?
If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?
in each media we require to use SLS? how to proceed?
what is the difference between potentiometric titration and karl fischer titration?
Why acetonitrile and water are used as extraction solvent when analysis melamine? I thought they are miscible and won't be able to separate...
Tell me about analytical method validation in QC
Why to use propyl paraben in HPLC gradient calibration
What is similarity factor and its use in api strength?
in which situation ion pair agent require to use?
analytical method validation require to with respect to release specification or shelf life specification?
What is intact assay method development.....?
What is third generation HPLC Columns?
if identification threshold crosses the limits then what next step?
In which situation we require to analytical method validation of excipient?
function of detecter in hplc ,gc and spectroscopy? function of carrier gas in gc?
