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¡¡¡¡¹ØÓÚ»ùÒò¶¾ÐÔÔÓÖÊ£¬£¬£¬ICH M7ÓÐÏêϸµÄ»ùÒò¶¾ÐÔÔÓÖÊ·ÖÀ࣬£¬£¬¸Å¿öÆðÀ´´óÖ·ÖΪÒÔϼ¸ÖÖ£º
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Impurity Class ÔÓÖÊÖÖ±ð |
Definition ½ç˵ |
Guidance for control ¿ØÖÆÖ¸µ¼ |
|
Class 1 |
Known mutagenic carcinogens ÒÑÖªÖÂÍ»±äÖ°©Îï |
Control at or below compoundspecific acceptable limit ¿ØÖÆÔÚ»¯ºÏÎïÌØÒìÐÔµÄÌؽÓÊÜÏÞ¶ÈÒÔÏ |
|
Class 2 |
Known mutagens with unknown carcinogenic potential (bacterial mutagenicity positive*, no rodent carcinogenicity data) Ö°©ÐÔδ֪µÄÒÑÖªÖÂÍ»±äÎϸ¾úÖÂÍ»±äÐÔÑôÐÔ*£¬£¬£¬ÎÞÄö³Ý¶¯ÎïÖ°©ÐÔÊý¾Ý£© |
Control at or below acceptable limits (appropriate TTC) ¿ØÖÆÔڿɽÓÊÜÏ޶ȣ¨ºÏÊʵÄTTC£©ÒÔÏ |
|
Class 3 |
Alerting structure, unrelated to the structure of the drug substance; no mutagenicity data ¾¯Ê¾½á¹¹£¬£¬£¬ÓëÖÊÁÏÒ©½á¹¹Î޹أ»£»£»ÎÞÖÂÍ»±äÐÔÊý¾Ý |
If non-mutagenic = Class 5 ÈçÎÞÖÂÍ»±äÐÔ£¬£¬£¬¹éΪ5Àà If mutagenic = Class 2 ÈôÓÐÖÂÍ»±äÐÔ£¬£¬£¬¹éΪ2Àà |
|
Class 4 |
Alerting structure, same alert in drug substance or compounds related to the drug substance ¾¯Ê¾½á¹¹£¬£¬£¬ÓëÖÊÁÏÒ©½á¹¹Óйأ»£»£»ÎÞÖÂÍ»±äÐÔÊý¾Ý |
Q3A Q3B
|
|
Class 5 |
No structural alerts, or alerting structure with sufficient data to demonstrate lack of mutagenicity or carcinogenicity ÎÞ¾¯Ê¾½á¹¹ |
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¡¡¡¡¹ØÓÚ´ó´ó¶¼Ò©ÎïµÄ»ùÒò¶¾ÐÔÔÓÖÊ£¬£¬£¬¿ÉÒÔÓÃLC-MS¼°GC-MSÀ´¾ÙÐмì²â£¬£¬£¬ÖÖÖÖÆÊÎöÊÖÒÕÒªÁìµÄʹÓðٷֱȼûÏÂ±í£º
¡¡¡¡¹ØÓÚÆÊÎöÒªÁìµÄÖÊÁ¿Ô´ÓÚÉè¼Æ£¬£¬£¬ÌÀ²©Ê¿¸üÊÇÓÐÒ»Ì××Ô¼ºÓÐÓõÄDOEÒªÁ죬£¬£¬¿ÉÒÔʹÓá°Óã¹Çͼ¡±»ò±í¸ñÐÎʽ£¬£¬£¬»®·ÖÆÊÎö¸÷²ÎÊýµÄ·çÏÕÒò×Ó£¬£¬£¬Æ¾Ö¤·çÏÕ¼¶±ðµÄ´óС£¡£¡£¡£¡£¡£¬£¬£¬È·¶¨ÆÊÎöÒªÁìÉè¼Æ¿Õ¼ä¡£¡£¡£¡£¡£¡£
| Risk for Low or High Assay/Impurity Results£¨º¬Á¿/ÓйØÎïÖÊ·çÏÕÆÀ¹À±í£© | |||||
| Risk Factor (Failure mode) |
Severity high=3 medium=2 low=1 |
Probability high=3 medium=2 low=1 |
Detectability high=1 medium=2 low=3 |
Numerical Rating S¡ÁP¡ÁD |
CQA |
| Environment | ¡¡ | ¡¡ | ¡¡ | ¡¡ | ¡¡ |
| Room Temperature | 1 | 1 | 1 | 1 | ¡¡ |
| Room Humidity£¨regular samples£© | 1 | 2 | 1 | 2 | ¡¡ |
| Room Humidity£¨hydroscopic samples£© | 3 | 2 | 1 | 6 | Y |
| Material | ¡¡ | ¡¡ | ¡¡ | ¡¡ | ¡¡ |
| sample | ¡¡ | ¡¡ | ¡¡ | ¡¡ | ¡¡ |
| Solvent£¨more risk on impurity£© | 2 | 2 | 2 | 8 | Y |
| Water£¨more risk on impurity£© | 2 | 2 | 2 | 8 | Y |
| Analyst | ¡¡ | ¡¡ | ¡¡ | ¡¡ | ¡¡ |
| Weighting | 3 | 2 | 2 | 12 | Y |
| Mixing | 3 | 2 | 2 | 12 | Y |
| Transferring | 3 | 2 | 2 | 12 | Y |
| Glassware | ¡¡ | ¡¡ | ¡¡ | ¡¡ | ¡¡ |
| Volumetric flask&Pipette | 3 | 2 | 1 | 6 | Y |
| Autosampler Vial £¨more risk on impurity£© | 3 | 1 | 2 | 6 | Y |
| Bottle & Baker | 1 | 1 | 2 | 2 | ¡¡ |
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