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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)

Appendices 384

1. Introduction 386

1.1. General requirements for stability testing 386

1.2. Specific requirements for stability testing of clinical samples 387

Basic Principles of Stability Testing Applied to Clinical Samples 390

2.1. Selection of batches and samples 390

2.2. Test criteria 390

2.3. Analytical procedures 390

2.4, Specifications 391

2.5. Storage conditions 392

2.6. Testing frequency 393

2.7. Storage period 393

2.8 Number of batches 393

1 1.3. Emulsions 258

11.4. Gels 259

9.References 259

1. Physical Stability of Solutions 263

1.1. Organoleptic testing 263

1.2. Subjective appearance testing 264

2. Parenteral Solutions 264

2.1. Swirly precipitates 265

2.2. Whiskers 266

2.3. Cloud times 266

2.4. Oral solutions 268

3. Disperse Systems 268

3.1. Suspensions 269

3.2. Sedimentation volumes 271

3.3. Sedimentation rates 273

3.4. Preservation stability 273

3.5. Dissolution of suspensions 274

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