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http://www.qikan.com.cn
鍘熸枡鑽浗闄呮敞鍐屼腑鍩哄洜姣掓�ф潅璐ㄧ殑娉曡瑙ｈ
浣滆�咃細鐜嬬澘鐫?/p>
鏉ユ簮锛氥�婁笂娴峰尰鑽�?/p>
2016
骞寸
15
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鎽?/p>
瑕?/p>
閬椾紶姣掔礌鏄竴绫绘瀬瀵屾寫鎴樻�х殑鏉傝川锛屽苟宸茶璇佹槑鍗充究鍦ㄤ綆娴撳害鏉′欢涓嬩緷鐒跺叿鏈夋瘨
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ICH
锛夐兘鐗瑰埆鎸?/p>
瀹氫簡瀹冧滑鍦ㄥ師鏂欒嵂鍜屾垚鍝佽嵂涓殑闄愰噺銆傞�氳繃瑙ｆ瀽鍘熸枡鑽湪缇庡浗鍜屾鐩熸敞鍐屼腑娑夊強鍒扮殑鍏充簬鍩哄洜
姣掓�ф潅璐ㄦ帶鍒剁殑娉曡锛屼负涓浗鍒惰嵂浼佷笟鎻愪緵鐩稿叧鎶�鏈寚瀵间互鎺ㄥ姩涓浗鑽搧鍑哄彛浜嬩笟鐨勫闀裤�?/p>
鍏抽敭璇?/p>
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鏉傝川
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涓浘鍒嗙被鍙凤細
R951
鏂囩尞鏍囪瘑鐮侊細
C
鏂囩珷缂栧彿锛?/p>
1006-1533
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2016
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15-0063-05
Introduction to regulations for genotoxic impurities in API registration
WANG Ruirui*
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Spectrum China Ltd.
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Shanghai 201611
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China
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ABSTRACT Genotoxic toxin is a very challenging impurity
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which has been proved to be toxic
even at low level. Thus ICH and other competent authorities in US and EU have established limitation
for genotoxic impurities in active pharmaceutical ingredients
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API
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and finished dosage form. The
US and EU regulations concerned with genotoxic impurities are elaborated so as to provide some
technical advices for Chinese drug manufacturers and make progress for the business of drug
exportation.
KEY WORDS active pharmaceutical ingredients
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API
锛夛紱
impurity
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genotoxicity
1
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ICH
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绫诲埆锛氭湁鏈烘潅璐ㄣ�佹棤鏈猴紙鍏冪礌锛夋潅璐ㄤ互鍙婃畫鐣欐憾鍓傘�傚湪杩欎笁绫讳腑锛岄仐浼犳瘨鎬ф潅璐ㄦ槸涓�绉嶇壒渚嬶紝
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DNA
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