SST is an integral procedure to be done in every drug product analysis (qualitative or quantitative). USP-(621) Chromatography gives the requirements for SST and acceptance criteria, unless it is specified in the specific USP-Monograph. Getting the results conform SST requirements means that you get the permission to go ahead with analysis the contrary means that some changes must be done within the frame of USP-(621) Chromatography. Normally with SST parameters we understand what is required by USP, EP,BP,JP,DAB, that is: %RSD<2%(5 injections) and %RSD>2%(6 injections), retention factor>2,tailing factor<1.5, selectivity>1 and resolution>1.5. Having such parameters means that system as whole works properly and you can proceed with the analysis.
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