<232>ELEMENTALIMPURITIES—,excipients,,beaddedintentionally,orbeintroducedinadvertently(.,byinteractionswithprocessingequipmentandthecontainerclosuresystem).Whenelementalimpuritiesareknowntobepresent,havebeenadded,orhavethepotentialforintroduction,-,cadmium,lead,andmercuy,they(attheminimum)mustbeconsideredintherisk-(binantornon-binantorigins),theirderivatives,ponents(.,conjugates)arewithinthescopeofthischapter,asaredrugproductscontainingsyntheticallyproducedpolypeptides,polynucleotides,,ines,cellmetabolites,DNAproducts,allergenicextracts,cells,wholeblood,ponentsorbloodderivativesincludingplasmaandplasmaderivatives,dialysatesolutionsnot<232>元素杂质-限度介绍本通则规定了制剂中元素杂质的限度。元素杂质包括催化剂和环境污染物,可能出现在原料药、辅料或制剂中。这些杂质可能本身就存在,也有可能是有意加入或无意引入的(如生产设备、密封容器系统间的相互作用)。当元素杂质已知存在、已经加入或有可能引入时,必须保证杂质符合规
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