| Q4 | | Pharmacopoeias
药典 |
| Q4A | | Pharmacopoeial Harmonisation
药典的同一化 |
| Q4B | Step 5 | Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH各地区使用的药典正文评估和建议 |
| Q4B Annex 1 (R1) | Step 5 | Residue on Ignition/Sulphated Ash General Chapter
关于ICH区域内药典附录的评价及建议-炽灼残渣（硫酸灰分）检查法 |
| Q4B Annex 2 (R1) | Step 5 | Test for Extractable Volume of Parenteral Preparations General Chapter
关于ICH区域内药典附录的评价及建议-注射剂装量检查法 |
| Q4B Annex 3 (R1) | Step 5 | Test for Particulate Contamination: Sub-Visible Particles General Chapter
关于ICH区域内药典附录的评价及建议-不溶性微粒检查法 |
| Q4B Annex 4A (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：微生物计数法 |
| Q4B Annex 4B (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：控制菌检查法 |
| Q4B Annex 4C (R1) | Step 5 | Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：原料药及其制剂的判定标准 |
| Q4B Annex 5 (R1) | Step 5 | Disintegration Test General Chapter
关于ICH区域内药典附录的评价及建议-崩解时限检查法 |
| Q4B Annex 6 | Step 5 | Uniformity of Dosage Units General Chapter
关于ICH区域内药典附录的评价及建议-含量均匀度检查法 |
| Q4B Annex 7 (R2) | Step 5 | Dissolution Test General Chapter
关于ICH区域内药典附录的评价及建议-溶出度检查法 |
| Q4B Annex 8 (R1) | Step 5 | Sterility Test General Chapter
关于ICH区域内药典附录的评价及建议-无菌检查法 |
| Q4B Annex 9 (R1) | Step 5 | Tablet Friability General Chapter
关于ICH区域内药典附录的评价及建议-片剂脆碎度检查法 |
| Q4B Annex 10 (R1) | Step 5 | Polyacrylamide Gel Electrophoresis General Chapter
关于ICH区域内药典附录的评价及建议-聚丙烯酰胺凝胶电泳法 |
| Q4B Annex 11 | Step 5 | Capillary Electrophoresis General Chapter
关于ICH区域内药典附录的评价及建议-毛细管电泳法 |
| Q4B Annex 12 | Step 5 | Analytical Sieving General Chapter
关于ICH区域内药典附录的评价及建议-筛分法 |
| Q4B Annex 13 | Step 5 | Bulk Density and Tapped Density of Powders General Chapter
关于ICH区域内药典附录的评价及建议-粉末的堆密度和拍实密度测定法 |
| Q4B Annex 14 | Step 5 | Bacterial Endotoxins Test General Chapter
关于ICH区域内药典附录的评价及建议-细菌内毒素检查法 |
