药物稳定性 348条(本栏目收费,不能显示细节,电话15274084725)
1 3.3. onc chromatographic methods 353
14. Regulatory and Compendia! Basis of Method Validation-Where to Start 353
15. Validation Protocol 354
16. Validation Parameters 356
16.1. USP General Chapter <1225>, Validation of Cornpendial Methods 356
16.3. FDA Reviewer Guidance 359
17. Definition of Validation Parameters 360
17.3. Specificity/ selectivity 362
17.4. Forced degradation 364
17.5. Detection limit (DL) 364
17.6. Quantitation limit (QL) 365
17.10. Application of Plackett- urman design to ruggedness testing 368
17.1 l. Stability of sample and standard solutions 369
17.12. System suitability specifications and tests 370
Post Validation Issues 372
18.1. After the laboratory work 373
18.3. Method transfer 375
Application of Validation Principles to Other Analytical Techniques 376
19.l. Cleaning method 376
Physicochemical characterization method (dissolution) 378
Nonchromatographic methods 378
Genera1 considerations 380