文檔庫

最新最全的文檔下載
當前位置:文檔庫 > Q3C R6 IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS中英文對照

Q3C R6 IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS中英文對照

ICH Q3C GUIDELINE FOR RESIDUAL SOLVENTS

IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS

Q3C (R6)-20161020

1.INTRODUCTION (2)

2.SCOPE OF THE GUIDELINE (3)

3.GENERAL PRINCIPLES (4)

3.1Classification of Residual Solvents by Risk Assessment (4)

3.2Methods for Establishing Exposure Limits (5)

3.3Options for Describing Limits of Class 2 Solvents (5)

3.4Analytical Procedures (7)

GR 92

3.5Reporting levels of residual solvents (7)

4.LIMITS OF RESIDUAL SOLVENTS (8)

4.1Solvents to Be Avoided (8)

4.2Solvents to Be Limited (9)

4.3Solvents with Low Toxic Potential (10)

4.4Solvents for which No Adequate Toxicological Data was Found (11)

------------------------------------------------------------------------------------------------------------------------------------------------------ICH Q3C GUIDELINE FOR RESIDUAL SOLVENTS 1/ 12

免費下載Word文檔免費下載: Q3C R6 IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS中英文對照

(共12頁)
长公开精准单双中特