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首页> 外文期刊>European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V >Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and th
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Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and th

机译：选择和验证用于原料身份控制的近红外光谱应用。欧盟关于制药行业使用近红外光谱法指导说明草案的实践经验

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Recently the CPMP/CVMP sent out for consultation the draft Note for Guidance (dNfG) on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization. We explored the practicability of this dNfG with respect to the verification of the correct identity of starting materials in a generic tablet-manufacturing site. Within the boundaries of the dNfG, a release procedure was developed for 12 substances containing structurally related compounds and substances differing only in particle size. For the method development literature data were also taken into consideration. Good results were obtained with wavelength correlation (WC), applied on raw spectra or second derivative spectra both without smoothing. The defined threshold of 0.98 for raw spectra differentiated between all molecular structures. Both methods were found to be robust over a period of 1 year. For the differentiation between the different particle sizes a subsequent second chemometric technique had to be used. Soft independent modelling of class analogy (SIMCA) with a probability level of 0.01 proved suitable. Internal and external validation I according to the dNfG showed no incorrect rejections or false acceptances. External validation II according to the dNfG was carried out with 95 potentially interfering substances from which 46 were tested experimentally. Macrogol 400 was not distinguished from macrogol 300. For the complete verification of the identity of macrogol 300 test A of the European Pharmacopoeia is needed in addition to the NIRS application. A release procedure developed with WC applied on raw spectra and SIMCA as a second method, which is different from the preferred method of the dNfG, was tested in practice with good results. We conclude that the dNfG has good practicability and that deviations from the preferred methods of the dNfG can also give good differentiation.
机译：最近，CPMP / CVMP发出了有关制药行业使用近红外光谱（NIRS）的指导说明（dNfG）草案的草案，并征询该文件的第二部分以供市场许可。我们探讨了这种dNfG的实用性，以验证通用片剂制造场所中原材料的正确身份。在dNfG的范围内，针对包含结构相关化合物和仅粒径不同的物质的12种物质开发了释放程序。对于方法开发，还考虑了文献数据。波长相关性（WC）应用于原始光谱或二阶导数光谱均获得了良好的结果，而没有进行平滑处理。原始光谱的定义阈值0.98在所有分子结构之间有所区别。发现这两种方法在1年内都是可靠的。为了区分不同的粒径，必须使用随后的第二化学计量技术。事实证明，类比的软独立建模（SIMCA）的可能性为0.01。根据dNfG，我进行的内部和外部验证均未显示错误拒绝或错误接受。根据dNfG进行的外部验证II是对95种潜在干扰物质进行的，其中46种经过实验测试。聚乙二醇400不能与聚乙二醇300区别开。为了完整验证聚乙二醇300的身份，除了NIRS应用外，还需要欧洲药典的测试A。在实践中测试了由WC应用于原始光谱和SIMCA作为第二种方法开发的释放程序，该方法不同于dNfG的首选方法，并获得了良好的结果。我们得出的结论是，dNfG具有良好的实用性，并且与dNfG的首选方法的偏离也可以带来很好的区分。

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