药物稳定性 348条(本栏目收费,不能显示细节,电话13136136841)
6. Step 5: Ongoing Stability Testing 472
6.2. Application of the basic principles 472
7. Step 6: Follow-Up Stability Testing 474
7.1. During continuous production 474
7.2. Variations and changes 475
cap 1 introductory overview 481
cap 2 solution kinetics 482
cap 3 kinetic pH profiles 483
cap 4 oxidation in solution 484
cap 5 calalysis complexation and photolysis 485
cap 6 solid state stability 486
cap 7 interactions of moisture with solids 487
cap 8 physical characteristics of solids 488
cap 10 physical testing 490
cap 11 development and validation of HPLC stability indicating assays 491
cap 12 stability of clinical trial materials 492
cap 13 a rational approach to stability testing and analytical developement for NCE drug substance and drug products 493
10.8. Role of the column 349
10.9. Role of temperature 350
10.10, Role of flow rate 350
11. Optimization (Optimizing the Separation) 351
11.1. Peak area or peak height for quantitation 351
l1.2. Plackett-Burman design 351
12. Computer Software for Method Development 351
13. Other Applications 352
13.1. Analytical method for cleaning assessment 352
13.2. Physicochemical characterization method (dissolution method) 352