How to set specification of assay, fisdolution and related substances?

how to qualify the impurity?

what is the acceptance criteria for enteric coated tablets in 0.1n hcl validation in each parameter?

What is the formula for relative diffrence for standard solution in solution stability in validation?

How require to perform linearity as per ANVISA? What are the acceptance criteria?

[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?

in api coa analytical method given as Ph Europe which api used in formulation in this api coa method given Ph Europe so for Analytical methic for finished product we require to refer Ph Europe monograph ok n.a.? So any extra impurities which is given in USP monograph of api or finished product need not require to monitor on above case n.a.? but how require to do specificity?

in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?

we can use expired sample for validation and analyst qualification?

If vendor having more imp than monograph then how to proceed? and how to set spec?

If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately

how require to set assay concentration for standard and sample?

What is dose dumping? why require to do?

Please give idea about method development for cleaning method and how maco level establish

What is mean by PDR?