Application of chemometric modelling to UV-Vis spectroscopy: development of simultaneous API and critical excipient assay in a liquid solution continuous flow

被引：3
作者：
Angheluta, Anamaria [1 ]
Guizani, Samd [1 ]
Saunier, Josselin [1 ]
Roennback, Robert [1 ]
机构：
[1] Ferring Int Ctr SA, Prod Supply Innovat Global Tech Operat Mfg Techno, St Prex, Switzerland
来源：
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY | 2020年 / 25卷 / 08期
关键词：
Continuous liquid manufacturing; chemometrics; partial least square (PLS); UV spectroscopy; Carbetocin; L-Methionine; content testing;
D O I：
10.1080/10837450.2020.1770789
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
By applying Chemometric modelling to UV-Vis spectroscopy, a single Multi-Variate Data Analysis predictive model, for in-line monitoring of two component concentrations in solution formulation, was developed. The purpose of this article is to summarize the experimental development work performed for the UV-Vis analytical method and calibration modelling to determine the content of active pharmaceutical ingredient Carbetocin and the content of one critical excipient (l-methionine) in PABAL (R) solution for injection 100 mu g/mL.
引用
收藏
页码：919 / 929
页数：11
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