Symeres has a dedicated group of chemists for the synthesis of reference standards to support our clients working in chemical development (CMC) and GMP production of APIs. For example, the synthesis of (i) impurities and decomposition products formed in API production, formulation studies, and storage of the drug substance or drug product; and (ii) analytical markers like (cold) labeled compounds (deuterated and 13C-labeled APIs). Examples include oxidized, hydroxylated, or hydrolyzed APIs with typical functional groups including N-oxides, hydroxylamines, and nitrosamines. A specific example is the synthesis of nitroso-pseudoephedrine (see scheme). The starting material (1S,2S)-(+)-pseudoephedrine (CAS 90-82-4) is a controlled substance (drug precursor category 1). Symeres has a license to import and store pseudoephedrine.
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.
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