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ivers12鐵桿木蟲(chóng) (小有名氣)
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[交流]
基因毒性雜質(zhì)研究
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請(qǐng)教一個(gè)問(wèn)題: 如果藥典中的某個(gè)已知雜質(zhì),含有和API不同的警示結(jié)構(gòu),是否需要按照基因毒性雜質(zhì)研究(這里暫不討論是否需要軟件預(yù)測(cè),只看警示結(jié)構(gòu)) 分為兩種情況: 1、藥典中明確該雜質(zhì)的限度 2、藥典中未明確該雜質(zhì)的具體限度 應(yīng)該如何處理呢? |

金蟲(chóng) (著名寫手)

銅蟲(chóng) (初入文壇)

鐵桿木蟲(chóng) (小有名氣)
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比如這個(gè)BP中的: Limits: — impurity A: maximum 0.2 per cent; — impurity F: maximum 0.15 per cent; — unspecified impurities: for each impurity, maximum 0.10 per cent; — total: maximum 0.4 per cent; — reporting threshold: 0.05 per cent. Specified impurities A, F. Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other/unspecified impurities and/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) B, C, D, E. 這種情況下,雜質(zhì)A,雜質(zhì)F,和雜質(zhì)B(含警示結(jié)構(gòu))的限度如何界定? |

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