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

Mostafa Essam  Ahmed Mostafa Eissa

doi:10.3923/asb.2024.24.35

What is it about?

The original article "Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient" provides a comprehensive examination of the key properties of active pharmaceutical ingredients (APIs) and the importance of effective quality control monitoring and investigation using SPC tools. It discusses various quality control techniques and their applications, offering valuable insights for pharmaceutical manufacturers and regulatory agencies.

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Why is it important?

The article "Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient" is important because: It addresses a critical issue in pharmaceutical manufacturing, especially in developing Asian countries: Ensuring the quality of APIs is essential for the safety and efficacy of pharmaceutical products. It provides a comprehensive overview of API quality control: The article covers a wide range of topics, including physical, chemical, and biological properties, offering valuable insights for industry professionals. It highlights the importance of effective monitoring and investigation: The article emphasizes the need for rigorous quality control measures to identify and address potential issues that could compromise the quality of APIs. It supports regulatory compliance: By providing information on current quality control practices and emerging trends, the article can help pharmaceutical manufacturers comply with regulatory requirements. Overall, this article is a valuable resource for anyone involved in the pharmaceutical industry, as it provides essential information for ensuring the quality and safety of pharmaceutical products.

Perspectives

The scientifically important perspective behind this article is the application of Statistical Process Control (SPC) to monitor and improve the quality of active pharmaceutical ingredients (APIs). Specifically, the study uses control charts and statistical analysis to: Assess the quality and consistency of Tinidazole, a pharmaceutical compound. Monitor the trending pattern and properties of the chemical over time. Detect changes and variations in the inspection characteristics of the API. The study highlights the importance of using statistical tools like control charts to ensure the quality of raw materials used in drug manufacturing. This is crucial for producing pharmaceutical dosage forms that are safe, effective, and of consistent quality.
Independent Researcher & Consultant Mostafa Essam Eissa

This page is a summary of: Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient, Asian Science Bulletin, February 2024, Science Alert,
DOI: 10.3923/asb.2024.24.35.
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Trending Perspective in Quality Control Monitoring and Investigation of Some Properties of Active Pharmaceutical Ingredient
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.

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Independent Researcher & Consultant Mostafa Essam Eissa

Ensuring Quality in Medicinal Compounds: A Research

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