Api或起始物料中亚硝酸盐限度

Limits of Nitrosamines
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请问有没有相关法规或者文献规定起始物料中亚硝酸盐的限度，以确保在后面可能产生的亚硝胺杂质不会超出标准。

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@x.h.yao Thanks for participating. A lot of discussions on whether a limit or specification should be establish for not just excipient but for any nitrite contributor. It is extremely hard to define specifications since the risk of Nitrosamines is very process specific. In one instance a limit will represent a risk for a particular formulation but in some other formulation that defined limit will not represent a risk. The limit and what level should be controlled are defined in the risk assessment.

Please refer to this post that illustrates how nitrite content is used to calculate those risks.

-Naiffer

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