娴锋鍖昏嵂鍥介檯閫氱敤鎶€鏈姹備笅鐨勮嵂鍝佽川閲忕爺绌
鍒嗙被锛
娴锋鎴愰暱钀
鍙戝竷鏃堕棿锛
2020-12-16
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Impurity Class 鏉傝川绫诲埆 |
Definition 瀹氫箟 |
Guidance for control 鎺у埗鎸囧 |
Class 1 |
Known mutagenic carcinogens 宸茬煡鑷寸獊鍙樿嚧鐧岀墿 |
Control at or below compoundspecific acceptable limit 鎺у埗鍦ㄥ寲鍚堢墿鐗瑰紓鎬х殑鐗规帴鍙楅檺搴︿互涓婞/p> |
Class 2 |
Known mutagens with unknown carcinogenic potential (bacterial mutagenicity positive*, no rodent carcinogenicity data) 鑷寸檶鎬ф湭鐭ョ殑宸茬煡鑷寸獊鍙樼墿锛堢粏鑿岃嚧绐佸彉鎬ч槼鎬?锛屾棤鍟娇鍔ㄧ墿鑷寸檶鎬ф暟鎹級 |
Control at or below acceptable limits (appropriate TTC) 鎺у埗鍦ㄥ彲鎺ュ彈闄愬害锛堝悎閫傜殑TTC锛変互涓婞/p> |
Class 3 |
Alerting structure, unrelated to the structure of the drug substance; no mutagenicity data 璀︾ず缁撴瀯锛屼笌鍘熸枡鑽粨鏋勬棤鍏筹紱鏃犺嚧绐佸彉鎬ф暟鎹?/p> |
If non-mutagenic = Class 5 濡傛棤鑷寸獊鍙樻€э紝褰掍负5绫狐/p> If mutagenic = Class 2 濡傛湁鑷寸獊鍙樻€э紝褰掍负2绫狐/p> |
Class 4 |
Alerting structure, same alert in drug substance or compounds related to the drug substance 璀︾ず缁撴瀯锛屼笌鍘熸枡鑽粨鏋勬湁鍏筹紱鏃犺嚧绐佸彉鎬ф暟鎹?/p> |
Q3A Q3B
|
Class 5 |
No structural alerts, or alerting structure with sufficient data to demonstrate lack of mutagenicity or carcinogenicity 鏃犺绀虹粨鏋凕/p> |
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銆€銆€瀵逛簬鍒嗘瀽鏂规硶鐨勮川閲忔簮浜庤璁★紝姹ゅ崥澹洿鏄湁涓€濂楄嚜宸辨湁鏁堢殑DOE鏂规硶锛屽彲浠ヤ娇鐢ㄢ€滈奔楠ㄥ浘鈥濇垨琛ㄦ牸褰㈠紡锛屽垎鍒垎鏋愬悇鍙傛暟鐨勯闄╁洜瀛愶紝鏍规嵁椋庨櫓绾у埆鐨勫ぇ灏忥紝纭畾鍒嗘瀽鏂规硶璁捐绌洪棿銆侟/p>
Risk for Low or High Assay/Impurity Results锛堝惈閲?鏈夊叧鐗╄川椋庨櫓璇勪及琛級 | |||||
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脳P脳D |
CQA |
Environment | 銆€ | 銆€ | 銆€ | 銆€ | 銆€ |
Room Temperature | 1 | 1 | 1 | 1 | 銆€ |
Room Humidity锛坮egular samples锛堻/td> | 1 | 2 | 1 | 2 | 銆€ |
Room Humidity锛坔ydroscopic samples锛堻/td> | 3 | 2 | 1 | 6 | Y |
Material | 銆€ | 銆€ | 銆€ | 銆€ | 銆€ |
sample | 銆€ | 銆€ | 銆€ | 銆€ | 銆€ |
Solvent锛坢ore risk on impurity锛堻/td> | 2 | 2 | 2 | 8 | Y |
Water锛坢ore risk on impurity锛堻/td> | 2 | 2 | 2 | 8 | Y |
Analyst | 銆€ | 銆€ | 銆€ | 銆€ | 銆€ |
Weighting | 3 | 2 | 2 | 12 | Y |
Mixing | 3 | 2 | 2 | 12 | Y |
Transferring | 3 | 2 | 2 | 12 | Y |
Glassware | 銆€ | 銆€ | 銆€ | 銆€ | 銆€ |
Volumetric flask&Pipette | 3 | 2 | 1 | 6 | Y |
Autosampler Vial 锛坢ore risk on impurity锛堻/td> | 3 | 1 | 2 | 6 | Y |
Bottle & Baker | 1 | 1 | 2 | 2 | 銆€ |
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