4. SFC applications for active pharmaceutical ingredient analysis
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Lu Zeng
Abstract
This chapter focuses on utilizing supercritical fluid chromatography (SFC) and its applications in drug development for the analysis of active pharmaceutical ingredient (API) in the manufacturing process. Various screening approaches such as sequential, parallel or tandem column chromatography offers a unique and useful tool for separations of impurities and optimizing the overall selectivity. With the new age of technology, modern SFC instruments can be qualified and chiral and achiral SFC methods can be validated for the GMP API release and/or cleaning testing under the regulatory guidelines. Thus, given the advantageous proprieties of CO2-based mobile phase and low consumption of solvents, we believe that this technology has become an equally valuable primary option for method development and validation in pharmaceutical industry analytical laboratories.
Abstract
This chapter focuses on utilizing supercritical fluid chromatography (SFC) and its applications in drug development for the analysis of active pharmaceutical ingredient (API) in the manufacturing process. Various screening approaches such as sequential, parallel or tandem column chromatography offers a unique and useful tool for separations of impurities and optimizing the overall selectivity. With the new age of technology, modern SFC instruments can be qualified and chiral and achiral SFC methods can be validated for the GMP API release and/or cleaning testing under the regulatory guidelines. Thus, given the advantageous proprieties of CO2-based mobile phase and low consumption of solvents, we believe that this technology has become an equally valuable primary option for method development and validation in pharmaceutical industry analytical laboratories.
Chapters in this book
- Frontmatter I
- Preface V
- Contents VII
- List of Contributors IX
- 1. Chiral preparative SFC 1
- 2. Supercritical fluid chromatography in bioanalysis 33
- 3. Ultrafast supercritical fluid chromatography 77
- 4. SFC applications for active pharmaceutical ingredient analysis 93
- 5. Analysis of terpenes (mono-, sesqui-, di-, and triterpenes) by SFE and SFC-MS 113
- 6. Synthesis in supercritical carbon dioxide 127
- 7. Applications of supercritical fluid chromatography in the field of edible lipids 163
- Index 189
Chapters in this book
- Frontmatter I
- Preface V
- Contents VII
- List of Contributors IX
- 1. Chiral preparative SFC 1
- 2. Supercritical fluid chromatography in bioanalysis 33
- 3. Ultrafast supercritical fluid chromatography 77
- 4. SFC applications for active pharmaceutical ingredient analysis 93
- 5. Analysis of terpenes (mono-, sesqui-, di-, and triterpenes) by SFE and SFC-MS 113
- 6. Synthesis in supercritical carbon dioxide 127
- 7. Applications of supercritical fluid chromatography in the field of edible lipids 163
- Index 189
