Identification and Detection of Pharmaceutical Impurities for Ensuring Safety Standard of Medicine: Hyphenated Analytical Techniques and Toxicity Measurements.

Abstract

Impurity separation and detection are essential processes in the pharmaceutical industry to preserve the quality of drugs as the impurities have the potential to significantly impair the therapeutic efficacy of an active ingredient and have negative effects on pharmaceutical formulations. The primary determinant of drug development is the creation of products that adhere to the highest standards of quality and safety, with a particular emphasis on effectively managing impurities in the therapeutic ingredients. To ensure that the resulting pharmaceutical possesses a high level of safety, meticulous identification, precise quantification, and stringent management of any extraneous components present in the drug ingredient need to be performed. The literature was compiled from different databases, such as DOAJ, PubMed, Research Gate, Google Scholar, Scopus, and Science Direct. Several organic and inorganic contaminants that are frequently present in final products and active pharmaceutical ingredients (APIs) were covered, along with the crucial section for quality control and fundamental details on their security, toxicity, detection limits, and quantification limitations. Pharmaceutical companies resolve the problem of the presence of impurities by adhering to strict regulatory requirements set by reputable agencies, like the ICH, USFDA, EMA, and PMDA. Also, impurity profiling is required for the regulatory submissions of new drug candidates. In some pharmacopoeias, impurity profiling and reporting are also included. To identify and measure contaminants, a variety of analytical techniques are employed, as discussed in this article. This paper covers the scientific features of contaminants present in pharmaceutical preparations, their prevention strategies, and the application of state-of-the-art analytical techniques for their detection.