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药物稳定性 348条(本栏目收费,不能显示细节,电话13136136841)
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