近红外光谱分析技术及其在药物分析中的应用.ppt

化学药品辅料库的建立 市场中常用的31种辅料 National Institutes for Food and Drug Control 欧巴代近红外导数化光谱图和滑石粉导数化光谱图 National Institutes for Food and Drug Control 药物多晶型(Polymorphisms)的鉴别 National Institutes for Food and Drug Control Absorbancein AU 三、应用NIR方法在线监测混合终点 Blend process‘ end point – homogeneous blend Beginning of the blend process National Institutes for Food and Drug Control Wavelength in nm Log(1/R) 四、药物存储稳定性的考察 0.3 0.2 0.1 0 -0.1 -0.2 -0.3 1000 1500 2000 Wavelength (nm) 2500 National Institutes for Food and Drug Control PC2(16.47%) 15 5 10 20 30 主成份分析:片剂的稳定性测试 25 20 测试状况1: 40 C at 70% Humidity 10 测试状况2: 25 C at 60% Humidity 0 -5 -10 -30 -20 -10 0 National Institutes for Food and Drug Control PC 1 (27.00%) 美洛西林对照品NIR监测方法的建立 谱段：6441.34-6495.34cm-1；光谱预处理方法：二阶导数（25点平滑） 阈值：3 National Institutes for Food and Drug Control 五、应用NIR方法对终产物进行放行检验 National Institutes for Food and Drug Control ? ? ? ? ? ? ? ? ? 六、应用于PAT的指导原则 Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations (draft), EMEA/CHMP/CVMP/QWP/17760/2009 Rev2, January 2012 Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Pharmaceutical CGMPs, September 2004 Guidance for Industry Process Validation: General Principles and Practices(R1), CGMP, January 2011 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations, Pharmaceutical CGMPs, September 2006 Guidance for Industry Q8(R2) Pharmaceutical Development, ICH, November 2009 Guidance for Industry Q9 Quality Risk Management, ICH, June 2006 Guidance for Industry Q10 Pharmaceutical Quality System, ICH, April 2009 Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4), ICH November 2011 Q11 Development and Manu