Hi, I have a question regarding to setting of SST in HPLC analyses (assay, purity of API and drug product). What is the most comon approach for repeatability? From 3 to 6 injections? Is it suitable to lower the number of injections? What is the comon approach for both types of methods?
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In general for assay test parameter, 05 injections shall be considered whereas for related substances parameter 06 injections shall be considered.