Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient

Abstract

Background and Objective:The production of pharmaceutical chemical compounds of predictable and reproducible quality is of paramount importance for manufacturing pharmaceutical dosage forms that meet the demands needed to achieve the necessary therapeutic properties. The study aims to use process-behavior charts and SPC software to control and inspect pharmaceutical compounds known as 1-(2-ethylsulfonyl)ethyl)-2-methyl-5-nitroimidazole. Materials and Methods: The study evaluates the quality of Tinidazole, a pharmaceutical chemical compound, from an Asian manufacturer. The compound is analyzed for loss-on-drying, melting point, assay and apparent density, according to the British Pharmacopeia standards. The analysis uses Minitab software and control charts to examine the distribution and trends of the data. Results: The datasets of the assay and apparent density followed a normal dispersion pattern. While the results of melting point and Loss-On-Drying (LOD) data failed the normality test. The approach for trending the data of the first two inspection characteristics is to use an Individual-Moving Range (I-MR) plot and to adjust the second two data types for the Laney-corrected attribute chart. Conclusion: Improvements are required to enhance the quality of inspection properties since there are signs of out-of-control points in some batches in the time series order. This study highlights the importance of the control charts in the examination of the quality of chemically manufactured materials.