Development and Validation of In-line Near-Infrared Spectroscopy Based Analytical Method for Commercial Production of a Botanical Drug Product

Publication date: Available online 2 July 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Shunnan Zhang, Haoshu Xiong, Lihong Zhou, Wei Ju, Zhexuan Yang, Kaijing Yan, Binjun Yan, Haibin QuAbstractNear-infrared (NIR) spectroscopy is one of the most successful pharmaceutical process analytical tools. For botanical drug products (BDPs), many studies have applied NIR spectroscopy for rapid analysis of botanical raw materials, extracts and formulations. However, the real-time process analysis reported for BDPs was still mainly conducted on lab- or pilot- scale equipment, where some essential conditions of the materials and process parameters can be easily controlled for NIR spectral measurement. Due to the chemical and physical characteristics of the commercial production of BDPs, it is challenging to develop in-line NIR methods with enough robustness for industrial-scale application. This is the first reported case study of the development and validation of the in-line NIR method for the commercial production of BDPs, taking Compound Danshen Dripping Pill (CDDP) as an example. An in-line NIR method was developed for simultaneous measurement of the three critical quality attributes, i.e. the relative density, the moisture content and the content of 3,4-dihydroxyphenyl lactic acid (danshensu, a key active compound), during the extract concentration process. The NIR spectra and sample collection lasted for three years (67 production batches) to cover the vari...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research