Nicergoline EP Impurity C (CAS 35155-28-3) is a structurally defined process-related impurity associated with the semisynthetic ergoline derivative nicergoline. With molecular formula C18H24N2O2 and molecular weight 300.4 g/mol, it belongs to the ergoline alkaloid class and is typically interpreted within impurity profiling as a synthetic intermediate or transformation product arising during side-chain construction or incomplete alkylation chemistry. Its positional and stereochemical relationship to the parent scaffold can complicate chromatographic resolution. Trace determination generally requires high-selectivity reversed-phase LC coupled to MS, often LC-MS/MS, with orthogonal confirmation by NMR where isolation is feasible.
References
SHINTOMI, KEIICHI, et al. “Pharmacological Effects of Nicergoline and Its Metabolites, Decomposition Products and Impurities in Animals.†Journal of Pharmacobio-Dynamics, vol. 10, no. 1, 1987, pp. 35–48, https://doi.org/10.1248/bpb1978.10.35 Winblad, Bengt, et al. “Nicergoline in Dementia.†CNS Drugs, vol. 14, no. 4, Oct. 2000, pp. 267–87, https://doi.org/10.2165/00023210-200014040-00003.
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