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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)
6. Step 5: Ongoing Stability Testing
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6.2. Application of the basic principles
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7. Step 6: Follow-Up Stability Testing
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7.1. During continuous production
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7.2. Variations and changes
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cap 1 introductory overview
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cap 2 solution kinetics
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cap 3 kinetic pH profiles
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cap 4 oxidation in solution
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cap 5 calalysis complexation and photolysis
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cap 6 solid state stability
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cap 7 interactions of moisture with solids
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cap 8 physical characteristics of solids
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cap 10 physical testing
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cap 11 development and validation of HPLC stability indicating assays
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cap 12 stability of clinical trial materials
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cap 13 a rational approach to stability testing and analytical developement for NCE drug substance and drug products
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10.8. Role of the column
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10.9. Role of temperature
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10.10, Role of flow rate
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11. Optimization (Optimizing the Separation)
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11.1. Peak area or peak height for quantitation
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l1.2. Plackett-Burman design
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12. Computer Software for Method Development
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13. Other Applications
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13.1. Analytical method for cleaning assessment
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13.2. Physicochemical characterization method (dissolution method)
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