The practice of Organic Chromatographic Screening, aimed at discovering, identifying, and (semi-)quantifying organic compounds in extracts from pharmaceutical container closure systems or medical devices, as well as in drug products, is relatively new to the Pharmaceutical and Medical Device Industries. This screening involves a combination of chromatographic techniques designed to cover a wide array of organic compounds, each possessing diverse physicochemical properties and chemical functionalities.
Typically, the screening process employs multiple chromatographic methods to achieve comprehensive coverage. Headspace Gas Chromatography/Mass Spectrometry (GC/MS) is used for analyzing Volatile Organic Compounds (VOCs), Gas Chromatography/Mass Spectrometry (GC/MS) is applied for Semi-Volatile Organic Compounds (SVOCs), and Liquid Chromatography/Mass Spectrometry (LC/MS) is utilized for Non-Volatile Organic Compounds (NVOCs). This multi-faceted approach ensures that a broad spectrum of organic substances can be effectively screened.
While Chromatographic Screening is an optimal solution for fulfilling its three primary functions—discovery, identification, and quantification—each of these functions is susceptible to specific errors inherent in the screening methodology. Discovery involves the initial detection of unknown compounds, which can be influenced by the sensitivity and specificity of the screening techniques used. Identification requires accurately determining the chemical structure of detected compounds, a process that can be complicated by the presence of similar compounds or complex mixtures. Quantification, or the measurement of the concentration of these compounds, must be precise and accurate, yet can be affected by factors such as calibration, instrument sensitivity, and the matrix effects of the sample being analyzed.
Despite these challenges, Organic Chromatographic Screening remains a critical tool in the pharmaceutical and medical device sectors. It enables the comprehensive analysis of compounds that may impact product safety, efficacy, and compliance. By understanding and mitigating the potential errors in each function of the screening process, these industries can improve the reliability and accuracy of their compound assessments, ultimately ensuring higher standards of quality and safety in their products.