Plugge W, van der Vlies C
Gist-brocades b.v., Quality Assurance Department, Industrial Pharmaceutical Products Division, Delft, The Netherlands.
J Pharm Biomed Anal. 1992 Oct-Dec;10(10-12):797-803. doi: 10.1016/0731-7085(91)80083-l.
The suitability of NIR spectroscopy as an alternative to several compendial test methods is discussed. Using ampicillin trihydrate as an example it is demonstrated that eight quality criteria are controlled by recording the NIR spectrum of a batch sample and calculating its Conformity Index.
讨论了近红外光谱法作为几种药典测试方法替代方法的适用性。以三水合氨苄西林为例,通过记录一批样品的近红外光谱并计算其一致性指数,证明了八个质量标准得到了控制。