Near-infrared spectroscopic and statistical process control methods for the quantitative control of the moisture content of calcium folinate drug reference substance

doi:10.19803/j.1672-8629.20230432

Abstract

Abstract: Objective To study quantitative model and quality control method for the determination of moisture content for chemical drug reference substances using near-infrared spectroscopy. To establish quality control chart combining statistical inference and multivariate calibration for the quality monitoring of moisture content for chemical drug reference substances. Methods Near-infrared spectroscopy quantitative model for the determination of moisture content of the reference substance was determined using calcium folinate reference substance after sub-packaging as the research object. Karl Fischer titration data was used as reference data. Statistical control chart was established, and the upper and lower limits of moisture determination values of calcium folinate chemical reference were determined. Non-destructive determination and quality control of moisture content by near-infrared spectroscopy were realized. Results The quantitative model of near-infrared moisture content determination established in this paper was robust and accurate, which can achieve the non-destructive determination of moisture content of calcium folinate reference substance, and the quality control of uniformity and stability of chemical reference substance during sub-packaging. Conclusion Near-infrared spectroscopic method combined with statistical quality control technic can be used as a new method for moisture content determination and to achieve online and non-destructive quality control of moisture content for chemical drug reference substances.

Key words: near-infrared spectroscopy, calcium folinate, statistical process control, non-destructive testing, multivariate calibration, moisture content

CLC Number:

R927.1

GENG Ying, LIU Yi, WANG Xuelei, TAN Dejiang, ZHU Rongdie, GUO Xianhui, CHEN Hua, ZHENG Li’e. Near-infrared spectroscopic and statistical process control methods for the quantitative control of the moisture content of calcium folinate drug reference substance[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1221-1227.

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