FDA对药物杂质的控制要求教学内容.pptVIP

练习-杂质控制限度的设置和论证 Active ingredient maximum daily dose Reporting Thresholds Identification Threshold* Qualification Threshold* ≤ 1g 0.1% N/A N/A 1g 0.05% N/A N/A 1mg N/A 1.0% or 5μg TDI N/A 1mg ~ 10mg N/A 0.5% or 20μg TDI N/A 10mg ~ 2g N/A 0.2% or 2mg TDI N/A 10mg N/A N/A 1.0% or 50μg TDI 10mg ~100mg N/A N/A 0.5% or 200μg TDI 100mg ~2g N/A N/A 0.2% or 3mg TDI 2g N/A 0.10% 0.15% Table 2. ICH Thresholds for Degradation Products in New Drug Products * Take the lower figure, % or total daily intake (TDI) 练习-杂质控制限度的设置和论证 Use the above Tables 1 and 2 as references and other knowledge you le