Impurities are chemical substances that are structurally related to the target drug but are not the active pharmaceutical ingredient (API) itself. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have strict guidelines regarding the identification, characterization, and control of impurities in pharmaceutical products. Impurity synthesis is crucial for ensuring that all impurities, including process-related impurities and degradation products, are well-understood and can be controlled within acceptable limits.
At Symeres, we have an established and specialized team of highly skilled chemists who are focused on the synthesis of reference standards for our customers’ projects. References standards are pivotal components in the pharmaceutical industry serving crucial roles in chemical development and the GMP production of APIs.
We are experts in the synthesis of impurities and decomposition products formed during API production, formulation studies, and storage of the drug substance or drug product. These impurities and decomposition products can arise from various chemical reactions and degradation processes that occur during the manufacturing and storage of pharmaceutical compounds. Accurate characterization and quantification of these impurities are essential for regulatory compliance and ensuring the safety and efficacy of the final drug product.
Furthermore, we have extensive experience with the synthesis of analytical markers such as (cold) labeled compounds (deuterated and 13C-labeled APIs). Analytical markers are compounds that serve as reference materials for the development and validation of analytical methods used in quality control and testing of pharmaceutical products. These markers are often used to calibrate analytical instruments and establish the identity and purity of APIs and drug products.
At Symeres we also have expertise in the synthesis of oxidized, hydroxylated, or hydrolyzed APIs with various functional groups including N-oxides, hydroxylamines, and nitrosamines (see scheme). These modified compounds are critical for understanding the potential degradation pathways of APIs and for developing analytical methods capable of detecting and quantifying these derivatives.
As well as synthesis, the isolation of impurities from process streams or formulations by preparative HPLC/SFC, followed by elucidation of the molecular structure by advanced NMR techniques and mass spectrometry is routinely carried out. Ultimately, the structure of the impurity is proved by synthesis, HPLC spiking experiments, and material supplied as a reference standard for CMC purposes.
At Symeres, our dedicated team of chemists play a vital role in ensuring the quality, safety, and regulatory compliance of pharmaceutical products by providing our clients with high-quality reference standards for impurities, decomposition products, and analytical markers. These reference standards are essential tools in the development, manufacturing, and quality control processes of pharmaceutical compounds.
Contact our experts directly via the form below!