Thanks to advances in analytical chemistry, trace levels of active pharmaceutical ingredients (API) have been discovered in the environment, especially in water systems, around the globe. Pharmaceuticals in the Environment (PIE) raises public interest and concerns among regulatory, scientific, environmental and media stakeholders. Although Environmental Risk Assessment (ERA) on APIs is now required by regulatory agencies such as the FDA and EMEA prior to new drug approval, a framework is still lacking to evaluate and monitor the potential impact on the environment once a new drug is launched. Only a small percentage of the total of over 3000 APIs have been studied for their occurrence and fate in environment. Models have been proposed to estimate the concentrations of APIs in aquatic environment. At Bristol-Myers Squibb (BMS), collective efforts have been initiated to advance the understanding of its drug products’ impact on the environment. Analytical chemistry plays an important role by providing analytical tools to monitor the occurrence of APIs post drug approval. Quantitative analytical methods for twelve APIs have been developed using solid phase extraction (SPE) and liquid chromatography with electrospray ionization source tandem mass spectrometry (LC-ESI-MS-MS). Multiple APIs are analyzed simultaneously. Stable isotopically labeled (SIL) analogs or structure analogs have been used as internal standards to improve method performance. Lower limits of quantification (LLOQ) as low as parts per trillion (ppt) are achieved.

Pharmaceuticals in the environment and water quality: The role of analytical chemistry

255th National Meeting (2018)

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