The total organic impurities for the drug product or drug substance is the sum of all impurities equal to or greater than their individual QL.

 
  • 3、所有的沒(méi)有記載的雜質(zhì),以及;4、總雜質(zhì)??傆袡C雜質(zhì)是指所有達到或超過(guò)其自身定量限度的雜質(zhì)的總量。
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